Trial Outcomes & Findings for Safety and Performance Study of Large Hole Vascular Closure Device FIV (NCT NCT03423602)

NCT ID: NCT03423602

Last Updated: 2023-02-01

Results Overview

Rate of major vascular access site complications related to the PerQseal® closure device (as defined by VARC-2)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 75 participants
• Primary outcome timeframe: up to 1 month post implantation
• Results posted on: 2023-02-01

Participant Flow

Patients from each of the participating centres undergoing an endovascular interventional procedure requiring a percutaneous common femoral arterial access using sheath sizes in the range of 12 to 20 F were screened against the inclusion/exclusion criteria for eligibility. If a patient met the requirements of the clinical investigation, they were invited to participate, given patient information relative to the study and if willing to participate were asked to sign informed consent.

Subjects with bilateral percutaneous access in both common femoral arteries, where both arteries met all eligibility criteria, were closed bilaterally with the Investigational device, at the discretion of the investigator. If a test device was used on both ipsilateral and contralateral femoral arteries, then each closure (i.e. each limb) was treated as an independent closure.

Unit of analysis: Limbs

Participant milestones

Measure	Investigational Device To confirm safety and performance of the PerQseal® Closure Device (DP2-FA1-4) and PerQseal® Introducers (DP2-FA1-5 and DP2-FA1-6) to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 12 to 20 F sheaths. PerQseal®: Large hole closure system
Overall Study STARTED	75 84
Overall Study Discharge	70 77
Overall Study 1-month Follow-up	66 71
Overall Study 3-month Follow-up	63 72
Overall Study COMPLETED	63 72
Overall Study NOT COMPLETED	12 12

Reasons for withdrawal

Measure	Investigational Device To confirm safety and performance of the PerQseal® Closure Device (DP2-FA1-4) and PerQseal® Introducers (DP2-FA1-5 and DP2-FA1-6) to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 12 to 20 F sheaths. PerQseal®: Large hole closure system
Overall Study Death	1
Overall Study Lost to Follow-up	6
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	4

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Investigational Device n=75 Participants To confirm safety and performance of the PerQseal® Closure Device (DP2-FA1-4) and PerQseal® Introducers (DP2-FA1-5 and DP2-FA1-6) to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 12 to 20 F sheaths. PerQseal®: Large hole closure system
Age, Continuous	78.7 years STANDARD_DEVIATION 8.0 • n=75 Participants
Sex: Female, Male Female	29 Participants n=75 Participants
Sex: Female, Male Male	46 Participants n=75 Participants
Region of Enrollment Ireland	5 participants n=75 Participants
Region of Enrollment Germany	70 participants n=75 Participants
Primary Procedure type TAVR	41 Participants n=75 Participants
Primary Procedure type EVAR	30 Participants n=75 Participants
Primary Procedure type TEVAR	4 Participants n=75 Participants
Height	170.1 cm STANDARD_DEVIATION 9.4 • n=75 Participants
Weight	80.8 kg STANDARD_DEVIATION 15.3 • n=75 Participants
Co-morbidity Hypertention	65 Participants n=75 Participants
Co-morbidity Diabetes	22 Participants n=75 Participants
Co-morbidity Severe acute non-cardiac systemic disease, autoimmune disease or terminal illness	0 Participants n=75 Participants
Co-morbidity Clinically significant peripheral vascular disease	2 Participants n=75 Participants
Co-morbidity Bleeding diatheses	2 Participants n=75 Participants
Co-morbidity Previous peripheral vascular surgery involving the aorta or lower extremities	4 Participants n=75 Participants
Co-morbidity Claudication	1 Participants n=75 Participants

PRIMARY outcome

Timeframe: up to 1 month post implantation

Population: All enrolled subjects with any major device related event. Includes all subjects through the last assessment prior to or at 1-month post implantation.

Rate of major vascular access site complications related to the PerQseal® closure device (as defined by VARC-2)

Outcome measures

Measure	Investigational Device n=75 Participants To confirm safety and performance of the PerQseal® Closure Device (DP2-FA1-4) and PerQseal® Introducers (DP2-FA1-5 and DP2-FA1-6) to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 12 to 20 F sheaths. PerQseal®: Large hole closure system
Major Vascular Complications [Safety]	0 Participants

SECONDARY outcome

Timeframe: up to 1 month from implantation

Population: All subjects with any minor device related event. Includes all subjects through the last assessment prior to or at 1-months

Rate of minor vascular access site complications directly related to the PerQseal® closure device (as defined by VARC-2)

Outcome measures

Measure	Investigational Device n=75 Participants To confirm safety and performance of the PerQseal® Closure Device (DP2-FA1-4) and PerQseal® Introducers (DP2-FA1-5 and DP2-FA1-6) to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 12 to 20 F sheaths. PerQseal®: Large hole closure system
Minor Vascular Complications [Safety] All enrolled subjects	5 Participants
Minor Vascular Complications [Safety] Subjects still enrolled at 1-month with follow-up	3 Participants

SECONDARY outcome

Timeframe: within 24 hours

Population: Technical success analysis included all closures that received the investigational device (79)

Percentage of closures (Limbs) with Technical Success, for the PerQseal® closure device, not requiring alternative therapy to achieve haemostasis

Outcome measures

Measure	Investigational Device n=79 Limbs To confirm safety and performance of the PerQseal® Closure Device (DP2-FA1-4) and PerQseal® Introducers (DP2-FA1-5 and DP2-FA1-6) to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 12 to 20 F sheaths. PerQseal®: Large hole closure system
Study Device Technical Success Rate [Performance]	75 Limbs

Adverse Events

Investigational Device

Serious events: 21 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	Investigational Device n=75 participants at risk To confirm safety and performance of the PerQseal® Closure Device (DP2-FA1-4) and PerQseal® Introducers (DP2-FA1-5 and DP2-FA1-6) to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 12 to 20 F sheaths. PerQseal®: Large hole closure system
Cardiac disorders Cardiac decompensation	5.3% 4/75 • Number of events 4 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Skin and subcutaneous tissue disorders Lymphocele	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Vascular disorders Access site haematoma	4.0% 3/75 • Number of events 3 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Vascular disorders Aneurysm	2.7% 2/75 • Number of events 2 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Cardiac disorders Arrhythmia - AV Block	4.0% 3/75 • Number of events 3 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Vascular disorders Arteriovenous fistula - access site	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Cardiac disorders Cardiac tamponade	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Vascular disorders Dissection	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Gastrointestinal disorders Gastrointestinal bleeding	2.7% 2/75 • Number of events 2 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Vascular disorders Haematoma	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Vascular disorders Hypertension	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Respiratory, thoracic and mediastinal disorders Pneumonia	2.7% 2/75 • Number of events 2 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Vascular disorders Graft occlusion	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Infections and infestations Infection	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Renal and urinary disorders Renal failure	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Blood and lymphatic system disorders Septicaemia	2.7% 2/75 • Number of events 2 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Nervous system disorders Spinal anterior syndrome	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Vascular disorders Stroke - ischemic	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Infections and infestations Urinary infection	1.3% 1/75 • Number of events 1 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.

Other adverse events

Measure	Investigational Device n=75 participants at risk To confirm safety and performance of the PerQseal® Closure Device (DP2-FA1-4) and PerQseal® Introducers (DP2-FA1-5 and DP2-FA1-6) to percutaneously close femoral artery punctures and to induce arterial haemostasis in patients undergoing endovascular procedures requiring an arteriotomy created by 12 to 20 F sheaths. PerQseal®: Large hole closure system
Vascular disorders Haematoma	4.0% 3/75 • Number of events 3 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.
Vascular disorders Pseudoaneurysm	2.7% 2/75 • Number of events 2 • From Subject enrolment to study exit which was 3-months ± 1-month Adverse Event definitions where those given in ISO 14155:2011. All adverse events were reported via the eCRF, whether or not they were related to the use of the test device or access closure procedure. All complications, SAEs, SADEs and USADEs were reviewed on a continuous basis by an independent Data Safety Monitoring Committee. All access site related complications were reviewed and adjudicated by an independent Clinical Events Committee. All safety data was 100% SDV during monitoring.

Additional Information

Dr Chris Martin

Vivasure Medical Ltd

Phone: +353 91 395 442

Email: chris.martin@vsuremed.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place