Trial Outcomes & Findings for Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System (NCT NCT03756558)

Last Updated: 2025-09-15

Results Overview

Freedom from major complications of the target limb. Major Complications include: access site vascular injury that requires surgical intervention, access related lower extremity ischemia, access site infection

Recruitment status

COMPLETED

Study phase

Target enrollment

147 participants

Primary outcome timeframe

30 days post procedure

Results posted on

2025-09-15

Participant Flow

Participant milestones

Participant milestones
Measure	Transfemoral Approach Closure of Common Femoral Artery site of subjects who have undergone interventional catheterization procedure using 8-18FR ID sheaths.
Overall Study STARTED	147
Overall Study COMPLETED	142
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Transfemoral Approach Closure of Common Femoral Artery site of subjects who have undergone interventional catheterization procedure using 8-18FR ID sheaths.
Overall Study Death	1
Overall Study Lost to Follow-up	2
Overall Study Withdrawal by Subject	2

Baseline Characteristics

Cross-Seal Closure Device IDE Trial - Study of the Cross-SealTM Suture-Mediated Vascular Closure Device System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Transfemoral Approach n=147 Participants Closure of Common Femoral Artery site of subjects who have undergone interventional catheterization procedure using 8-18FR ID sheaths.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=5 Participants
Age, Categorical >=65 years	130 Participants n=5 Participants
Age, Continuous	76.0 years STANDARD_DEVIATION 10.05 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	105 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	132 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	8 Participants n=5 Participants
Region of Enrollment United States	147 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post procedure

Population: Pivotal safety cohort included 96 subjects from the full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. Due to missing data from 8 subjects, the analysis was conducted with 88 subjects.

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=88 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Freedom From Major Complications	83 Participants

PRIMARY outcome

Timeframe: Index Procedure

Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Number of participants analyzed is 101 as 9 subjects who had an adjunctive intervention and 4 subjects who did not receive the investigational device.

The mean Time To Hemostasis in the Common Femoral Artery (CFA) of the target limb access site with use of the investigational device.

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=101 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Mean Time To Hemostasis (TTH)	0.4 Minutes Standard Deviation 1.4

SECONDARY outcome

Timeframe: 30 days post procedure

Population: Pivotal safety cohort included 96 subjects from full analysis set, comprising all enrolled and treated subjects who experienced at least one component for the safety endpoint or were follow-up to the lower limit of the follow-up window for each time point. Due to missing data from 8 subjects, the analysis was conducted with 88 subjects.

The freedom from minor complications at the target limb access site. Minor Complications include: pseudoaneurysm at the access site, access site hematoma over 10cm, access site wound dehiscence

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=88 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Freedom From Minor Complications	84 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Number of subjects with devices related complications as adjudicated by the Clinical Events Committee.

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=88 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Number of Participants With Device Related Complications Within 30 Days Post-procedure	9 Participants

SECONDARY outcome

Timeframe: 60 days post procedure

Incidence of major and minor Adverse Events (AEs)

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=96 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Incidence of Adverse Events	62 Participants

SECONDARY outcome

Timeframe: Immediately Post-procedure (procedure approximately 8 hours)

Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 4 subjects, the analysis was conducted on 110 subjects.

Incidence of hemostasis with the investigational device without the need for any access-site-related adjunctive surgical or endovascular intervention (target limb only).

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=110 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Incidence of Technical Success	102 Participants

SECONDARY outcome

Timeframe: Within 48 hours of the index procedure or hospital discharge, whichever occurs first

Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 2 subjects, the analysis was conducted on 112 subjects.

Incidence of access site closure success: defined as technical success and freedom from major complications

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=112 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Incidence of Closure Success	99 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 3 subjects, the analysis was conducted on 111 subjects.

Incidence of Treatment Success: defined as technical success and freedom from major complications

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=111 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Incidence of Treatment Success	98 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 4 subjects, the analysis was conducted on 110 subjects.

Subjects requiring adjunctive surgical or endovascular intervention to achieve hemostasis of the access site (target limb only) including type of adjunctive intervention.

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=110 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Incidence of Surgical or Endovascular Intervention Post Closure	8 Participants

SECONDARY outcome

Timeframe: Post-procedure, following use of the investigational device until achieve hemostasis, assessed approximately up to 48 hours

Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 3 subjects, the analysis was conducted on 111 subjects.

Incidence of subjects requiring adjunctive manual compression following use of the investigational device to achieve hemostasis of the access site (target limb only).

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=111 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Incidence of Manual Compression	31 Participants

SECONDARY outcome

Timeframe: From the final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding, assessed up to approximately 48 hours

Population: Pivotal Effectiveness cohort included 114 subjects from the full analysis set, comprising all enrolled and treated without adjunctive therapy. To account for early study termination due to COVID-19 concerns, the last 18 subjects Roll-in subjects were included in the pivotal cohort (96 subjects). Due to missing data from 6 subjects, the analysis was conducted on 108 subjects.

Time-to-Ambulation: defined as elapsed time from final procedural sheath removal to time when the subject stands and walks at least 20 feet without re-bleeding.

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=108 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Time-to-Ambulation:	15.9 Hours Standard Deviation 14.65

SECONDARY outcome

Timeframe: 30 days post procedure

Incidence of subjects experiencing Device Failure.

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=114 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Incidence of Device Failure	0 Participants

SECONDARY outcome

Timeframe: 30 days post procedure

Number of subjects with procedure related complications as adjudicated by the CEC.

Outcome measures

Outcome measures
Measure	Transfemoral Approach n=88 Participants Closure of common femoral artery site of subjects who have undergone interventional catheterization procedures using 8-18Fr ID sheaths
Incidence of Procedure Related Complications	9 Participants

Adverse Events

Cross-Seal System

Serious events: 42 serious events

Other events: 63 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Cross-Seal System n=147 participants at risk The Cross-Seal System will be used in all subjects enrolled in the study Cross-Seal System: Use of the Cross-Seal system to close the femoral arteriotomy
Renal and urinary disorders Acute kidney injury	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Metabolism and nutrition disorders Acute respiratory failure	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Blood and lymphatic system disorders Anemia	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Aortic dissection	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Arterial perforation	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Congenital, familial and genetic disorders Arteriovenous malformation	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Musculoskeletal and connective tissue disorders Arthralgia	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Atrial fibrillation	2.0% 3/147 • Number of events 3 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Atrioventricular block	2.0% 3/147 • Number of events 3 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Atrioventricular block complete	2.0% 3/147 • Number of events 3 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Atrioventricular block first degree	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Blood and lymphatic system disorders Blood loss anaemia	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Bradycardia	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Infections and infestations Bronchitis	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Cardiac failure congestive	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Cardiac tamponade	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Cardio-respiratory arrest	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Coronary artery disease	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Product Issues Device dislocation	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Investigations Electrocardiogram PR prolongation	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Femoral artery dissection	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Musculoskeletal and connective tissue disorders Groin Pain	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Investigations Haemoglobin decreased	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Musculoskeletal and connective tissue disorders Hip fracture	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Meningioma	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Gastrointestinal disorders Nausea	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Nervous system disorders Neuropathy peripheral	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Infections and infestations Osteomyelitis	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Peripheral artery occlusion	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Peripheral artery stenosis	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Infections and infestations Pneumonia	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Pyrexia	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Metabolism and nutrition disorders Respiratory failure	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Gastrointestinal disorders Retroperitoneal haematoma	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Gastrointestinal disorders Retroperitoneal haemorrhage	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Stent-graft endoleak	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Syncope	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Nervous system disorders Tremor	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Infections and infestations Urinary tract infection	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Vascular access site haematoma	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Vascular access site haemorrhage	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Injury, poisoning and procedural complications Vascular graft occlusion	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Ventricular tachycardia	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Infections and infestations Wound infection	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.

Other adverse events

Other adverse events
Measure	Cross-Seal System n=147 participants at risk The Cross-Seal System will be used in all subjects enrolled in the study Cross-Seal System: Use of the Cross-Seal system to close the femoral arteriotomy
Renal and urinary disorders Acute kidney injury	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Blood and lymphatic system disorders Anaemia	2.7% 4/147 • Number of events 4 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Blood and lymphatic system disorders Anaemia postoperative	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Arrhythmia	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Arteriovenous fistula	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Asthenia	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Atheroembolism	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Atrial fibrillation	2.0% 3/147 • Number of events 3 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Balance disorder	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Investigations Blood creatinine increased	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Bundle Branch Block Left	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Burning sensation	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Cardiac failure congestive	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Investigations Carotid bruit	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Catheter site pain	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Chest discomfort	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Chest pain	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Gastrointestinal disorders Constipation	2.0% 3/147 • Number of events 3 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Ear and labyrinth disorders Deafness unilateral	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Psychiatric disorders Delirium	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Gastrointestinal disorders Diverticulum	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Dizziness	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Ecchymosis	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Blood and lymphatic system disorders Ecchymosis	2.0% 3/147 • Number of events 3 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Investigations Electrocardiogram QRS complex prolonged	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Skin and subcutaneous tissue disorders Erythema	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Injury, poisoning and procedural complications Fall	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Musculoskeletal and connective tissue disorders Flank pain	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Gastrointestinal disorders Gastroenteritis viral	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Musculoskeletal and connective tissue disorders Groin Pain	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Haematoma	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Renal and urinary disorders Haematuria	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Nervous system disorders Headache	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Hypertension	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Nervous system disorders Hypoaesthesia	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Hypotension	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Skin and subcutaneous tissue disorders Ingrowing nail	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Intermittent claudication	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Musculoskeletal and connective tissue disorders Myalgia	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Gastrointestinal disorders Nausea	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Nodule	2.7% 4/147 • Number of events 4 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Oedema peripheral	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Infections and infestations Onychomycosis	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Palpitations	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Peripheral artery stenosis	2.7% 4/147 • Number of events 4 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Peripheral artery thrombosis	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Peripheral swelling	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Blood and lymphatic system disorders Petechiae	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Injury, poisoning and procedural complications Procedural nausea	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Procedural pain	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Gastrointestinal disorders Rectal tenesmus	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Shock	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Stenosis	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Syncope	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Blood and lymphatic system disorders Thrombocytopenia	2.0% 3/147 • Number of events 3 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Nervous system disorders Tremor	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Renal and urinary disorders Urinary retention	2.7% 4/147 • Number of events 4 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Vascular access site bruising	2.0% 3/147 • Number of events 3 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Vascular access site haematoma	2.0% 3/147 • Number of events 3 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Vascular disorders Vascular access site haematoma	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Vascular access site haemorrhage	3.4% 5/147 • Number of events 5 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Vascular access site pseudoaneurysm	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
General disorders Vascular access site thrombosis	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Injury, poisoning and procedural complications Vascular pseudoaneurysm	1.4% 2/147 • Number of events 2 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.
Cardiac disorders Ventricular fibrillation	0.68% 1/147 • Number of events 1 • From time of enrollment through study completion (up to 60 days). Evaluation of all Adverse Events (AEs) from time of investigational device use within 30 days post-procedure, and through 60 days post-procedure for subjects requiring a repeat DUS, including major and minor complications.

Additional Information

Director of Clinical Operations

Terumo Medical Corporation

Phone: 9085146154

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60