Trial Outcomes & Findings for Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE) (NCT NCT00880230)

Last Updated: 2016-02-26

Results Overview

The analysis is based on the percentage of Intent to Treat subjects (ITT) who experienced the primary endpoint or who had adequate follow-up for the 9-month analysis. A subject had adequate follow-up if he/she had an event or had a follow-up of at least 256 days, allowing for a visit window of 9 months +/- 14 days.

Recruitment status

COMPLETED

Study phase

Target enrollment

141 participants

Primary outcome timeframe

In-hospital and 9 Months

Results posted on

2016-02-26

Participant Flow

Recruitment was for a period of 16 months. Subjects were recruited at medical clinics who participate in clinical trials.

Participant milestones

Participant milestones
Measure	Scuba Iliac Stent System Device: Scuba Iliac Stent Scuba Iliac Stent System: The Scuba Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Overall Study STARTED	141
Overall Study COMPLETED	134
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Iliac Artery Treatment With The Invatec Scuba™ Cobalt Chromium Stent (INTENSE)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ Iliac stent Scuba Iliac Stent System: The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	85 Participants n=5 Participants
Age, Categorical >=65 years	56 Participants n=5 Participants
Age, Continuous	63.90 years STANDARD_DEVIATION 9.55 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	108 Participants n=5 Participants
Region of Enrollment United States	59 participants n=5 Participants
Region of Enrollment Germany	70 participants n=5 Participants
Region of Enrollment Switzerland	12 participants n=5 Participants

PRIMARY outcome

Timeframe: In-hospital and 9 Months

Population: Intent to Treat Population (ITT)

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Composite of Major Adverse Events (MAE) Defined as the Occurrence of In-hospital Myocardial Infarction (MI) or Target Segment Revascularization, Target Limb Loss, or Death Within 9 Months Post-procedure.	5.2 Percentage of Participants Interval 2.1 to 10.5

SECONDARY outcome

Timeframe: 30 Days

Population: Intent to Treat Population (ITT)

The analysis is based on the number of patients who experienced either an MI, died, had a stroke, stent thrombosis, distal embolization, arterial rupture/perforation limb ischemia, lost a target limb, or had a bleeding event due to the procedure within 30 days after being treated with the Scuba iliac stent.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Major Adverse Vascular Events Through 30 Days as a Composite of (MI, Death or Stroke, Stent Thrombosis, Distal Embolization, Arterial Rupture/Perforation, Acute Limb Ischemia, Target Limb Loss, Procedure-related Bleeding Event Requiring Transfusion)	2.2 Percentage of Patients Interval 0.5 to 6.2

SECONDARY outcome

Timeframe: At time of deployment

Population: Intent to Treat Population (ITT)

The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Device Success	95 Percentage of Patients Interval 90.0 to 98.0

SECONDARY outcome

Timeframe: Up to the moment the catheter sheath introducer has been removed

Population: Intention to Treat Population (ITT)

The outcome is based on the successful delivery and deployment of the Scuba iliac stent and the intact retrieval of the delivery system \[Device Success\] and the achievement of \<30% residual stenosis immediately after stent deployment, without occurrence of in-hospital Major Adverse Events (MAE).

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Procedural Success	86.5 Percentage of Patients Interval 79.8 to 91.7

SECONDARY outcome

Timeframe: 30 Days

Population: Intention to Treat Population (ITT)

Early Clinical Success (30 days) is defined as improvement of the Rutherford-Becker scale criteria by greater than or equal to one category as obtained at the 30 day follow-up visit.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Clinical Success	93.8 Percentage of Patients Interval 88.2 to 97.3

SECONDARY outcome

Timeframe: 6 Months

Population: Intention to Treat Population (ITT)

Late Clinical Success (6 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Clinical Success	69.3 Percentage of Patients Interval 60.0 to 77.6

SECONDARY outcome

Timeframe: 9 Months

Population: Intent to Treat Population (ITT)

Late Clinical Success (9 months) is defined as a maintained improvement in Ankle-Brachial Index (ABI) or Thigh-Brachial Index (TBI) assessed as either a) normalized (0.90) or b) an increase by 0.1 from the baseline level and had not decreased by more than 0.15 from the maximum result observed immediately post-procedure. In the absence of ABI/TBI data, Late Clinical Success was assessed in the same manner as Early Clinical Success.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Clinical Success	66.4 Percentage of Patients Interval 57.2 to 74.8

SECONDARY outcome

Timeframe: 6 Months

Population: Intention to Treat Population (ITT)

Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 6 months.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Patency - Primary	94.9 Percentage of Patients Interval 89.7 to 97.9

SECONDARY outcome

Timeframe: 6 Months

Population: Intention to Treat (ITT)

Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 6 months.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Patency - Primary Assisted	1.5 Percentage of Patients Interval 0.2 to 5.2

SECONDARY outcome

Timeframe: 6 Months

Population: Intention to Treat Population (ITT)

Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 6 months.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Patency - Secondary	3.7 Percentage of Patients Interval 1.2 to 8.4

SECONDARY outcome

Timeframe: 9 Months

Population: Intention to Treat (ITT)

Patients were assumed primary patent if the target vessel had continuous flow without revascularization, bypass, or amputation at 9 months.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Patency - Primary	95.3 Percentage of Patients Interval 89.3 to 98.5

SECONDARY outcome

Timeframe: 9 Months

Population: Intention to Treat (ITT)

Primary assisted patency is defined as continuous flow assisted with a revascularization when the target vessel has restenosed (0-99%) at any time post-procedure through 9 months.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Patency - Primary Assisted	1.9 Percentage of Patients Interval 0.2 to 6.6

SECONDARY outcome

Timeframe: 9 Months

Population: Intention to Treat Population (ITT)

Secondary patency is defined as reestablishment of flow to distal arteries after 100% occlusion has occurred at the target vessel at post-procedure through 9 months.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Patency - Secondary	1.9 Percentage of Patients Interval 0.2 to 6.6

SECONDARY outcome

Timeframe: 9 Months

Population: Intention to Treat Population (ITT)

Restenosis is defined as a 50% or greater diameter stenosis observed post-procedure through the 9 month timepoint. Restenosis is initially assessed by Duplex Ultrasound of the iliac artery with the common femoral artery.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Target Limb Revascularization	7.5 Percentage of Patients Interval 3.6 to 13.3

SECONDARY outcome

Timeframe: 9 Months

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Restenosis Rate (≥ 50% Diameter Stenosis by Duplex Ultrasound Determination)	1.9 Percentage of Patients Interval 0.2 to 6.6

SECONDARY outcome

Timeframe: 9 Months

Population: Intention to Treat Population (ITT)

Death can be classified as one of three categories: cardiac, vascular, or non-cardiovascular. All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Death	1.5 Percentage of Patients Interval 0.2 to 5.3

SECONDARY outcome

Timeframe: 9 Months

Population: Intention to Treat Population (ITT)

Amputation of the target limb by surgical removal of tissue anywhere from the toe to hip in the ipsilateral limb of the target segment. Amputations are subclassified as: Above the knee, Below the knee, Transmetatarsal, and Toe.

Outcome measures

Outcome measures
Measure	Scuba Iliac Stent System n=141 Participants Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Target Limb Loss	0 Percentage of Patients Interval 0.0 to 1.0

Adverse Events

Scuba Iliac Stent System

Serious events: 47 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Scuba Iliac Stent System n=141 participants at risk Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Blood and lymphatic system disorders Anaemia	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Cardiac disorders Acute Coronary Syndrome	2.1% 3/141 • Number of events 3 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Cardiac disorders Acute Myocardial Infarction	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Cardiac disorders Angina Pectoris	2.8% 4/141 • Number of events 6 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Cardiac disorders Angina Unstable	0.71% 1/141 • Number of events 2 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Cardiac disorders Atrial Fibrilation	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Cardiac disorders Cardiac Arrest	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Cardiac disorders Coronary Artery Disease	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Cardiac disorders Coronary Artery Stenosis	1.4% 2/141 • Number of events 2 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Ear and labyrinth disorders Vertigo	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Gastrointestinal disorders Abdominal Pain	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Gastrointestinal disorders Gastric Ulcer	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Gastrointestinal disorders Gastritis Erosive	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Gastrointestinal disorders Pancreatitis	0.71% 1/141 • Number of events 2 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
General disorders Catheter Site Haemorrhage	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
General disorders Tenderness	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Infections and infestations Pneumonia	2.1% 3/141 • Number of events 3 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Infections and infestations Post Procedural Infection	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Injury, poisoning and procedural complications In-stent Arterial Restenosis	1.4% 2/141 • Number of events 3 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Injury, poisoning and procedural complications Meniscus Lesion	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Injury, poisoning and procedural complications Stent Occlusion	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Injury, poisoning and procedural complications Thrombus in Device	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Injury, poisoning and procedural complications Wound	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Metabolism and nutrition disorders Diabetic Ketoacidosis	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Musculoskeletal and connective tissue disorders Arthritis	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Musculoskeletal and connective tissue disorders Cervical Spinal Stenosis	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Musculoskeletal and connective tissue disorders Intervertebral Disc Protrusion	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Musculoskeletal and connective tissue disorders Musculoskeletal Pain	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Musculoskeletal and connective tissue disorders Pain in Extremity	1.4% 2/141 • Number of events 2 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast Cancer Recurrent	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon Cancer	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung Neoplasm Malignant	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Oesophageal Carcinoma	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate Cancer	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Rectal Cancer	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Nervous system disorders Carotid Artery Stenosis	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Nervous system disorders Dizziness	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Psychiatric disorders Bipolar Disorder	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Renal and urinary disorders Calculus Ureteric	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Renal and urinary disorders Renal Artery Stenosis	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Renal and urinary disorders Renal Failure Acute	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Respiratory, thoracic and mediastinal disorders Respiratory Failure	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Aortic Aneurysm	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Arterial Thrombus Limb	0.71% 1/141 • Number of events 2 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Femoral Arterial Stenosis	2.1% 3/141 • Number of events 3 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Hypertensive Emergency	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Iliac Artery Occlusion	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Iliac Artery Stenosis	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Iliac Artery Thrombosis	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Intermittent Claudication	5.0% 7/141 • Number of events 8 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Leriche Syndrome	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Peripheral Artery Dissection	0.71% 1/141 • Number of events 2 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Peripheral Embolism	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Peripheral Ischaemia	1.4% 2/141 • Number of events 2 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Subclavian Artery Stenosis	0.71% 1/141 • Number of events 1 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).

Other adverse events

Other adverse events
Measure	Scuba Iliac Stent System n=141 participants at risk Device: Scuba™ iliac stent Scuba Iliac Stent System : The Scuba™ Stent System consists of a balloon-expandable stent and an over the wire (OTW) delivery system.
Cardiac disorders Acute Coronary Syndrome	2.1% 3/141 • Number of events 3 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Cardiac disorders Angina Pectoris	2.8% 4/141 • Number of events 7 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
General disorders Catheter Site Haematoma	2.8% 4/141 • Number of events 4 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Infections and infestations Pneumonia	2.1% 3/141 • Number of events 3 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Musculoskeletal and connective tissue disorders Pain in Extremity	3.5% 5/141 • Number of events 6 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Femoral Artery Stenosis	2.8% 4/141 • Number of events 4 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Intermittent Claudication	6.4% 9/141 • Number of events 13 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).
Vascular disorders Peripheral Artery Dissection	2.1% 3/141 • Number of events 4 • From subject index procedure through the 9 month follow-up visit period. In this study, subjects were encouraged to report adverse events (AEs) spontaneously or in response to general, non-directed questioning (e.g., "How has your health been since the last visit?"). Any time during the study, the subject may volunteer information that resembles an adverse event (AE).

Additional Information

Arslan Malik - Senior Clinical Research Manager

Medtronic Aortic and Peripheral Vascular

Phone: (707) 541-3256

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Medtronic has a legitimate interest in ensuring that a multi-center publication is the first publication to be released regarding the completed Study. The Institution agrees that it will not publish or disclose any results of or information pertaining to the study until a multi-center publication is released. If a publication is not released within one year after completion of the study, the Institution will have the right to publish information pertaining to their activities conducted.
Publication restrictions are in place

Restriction type: OTHER