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The Complete® SE SFA Study for the Treatment of SFA/PPA Lesions

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00814970
Recruitment Status : Completed
First Posted : December 25, 2008
Results First Posted : May 21, 2014
Last Update Posted : April 13, 2016
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Peripheral Vascular Disease
Intervention Device: Complete SE Vascular Stent System
Enrollment 196
Recruitment Details Recruitment was for a period of 20 months. Subjects were recruited at medical clinics who participate in clinical trials.
Pre-assignment Details  
Arm/Group Title Complete Self-expanding (SE) Vascular Stent System
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Device: Complete Self-expanding (SE) Vascular Stent System >

> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Period Title: Overall Study
Started 196
Completed 146
Not Completed 50
Arm/Group Title Complete SE Vascular Stent System
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Device: Complete SE Vascular Stent System>

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Baseline Participants 196
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 196 participants
<=18 years
0
   0.0%
Between 18 and 65 years
74
  37.8%
>=65 years
122
  62.2%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 196 participants
68.7  (10.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 196 participants
Female
72
  36.7%
Male
124
  63.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 196 participants
United States 133
Germany 48
Belgium 15
1.Primary Outcome
Title Major Adverse Event (MAE) Rate
Hide Description Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat Population
Arm/Group Title Complete SE Vascular Stent System
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Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
11.0
2.Primary Outcome
Title Primary Patency Rate
Hide Description Primary patency defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment, with no restenosis ≥ 50% as documented by peak systolic velocity ratio ≥2.0 as assessed by duplex ultrasound (DUS).
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
72.6
3.Secondary Outcome
Title Major Adverse Event (MAE) Rate
Hide Description Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 30 day timepoint.
Time Frame 30 days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
0.5
4.Secondary Outcome
Title Major Adverse Event (MAE) Rate
Hide Description Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 6 month timepoint.
Time Frame 6 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
4.1
5.Secondary Outcome
Title Device Success
Hide Description The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using only the assigned device.
Time Frame At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of lesions treated
90.0
6.Secondary Outcome
Title Lesion Success
Hide Description The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion using either the Complete SE SFA Stent System or other standard percutaneous devices.
Time Frame At time of deployment to the end of the treatment procedure (removal of vascular sheath from the patient).
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of lesions treated
90.0
7.Secondary Outcome
Title Procedure Success
Hide Description The outcome is based on the angiographic evidence of <30% final residual stenosis of the target lesion after stent implantation and no occurrence of a procedure-related Major Adverse Events (MAE) prior to hospital discharge.
Time Frame At time of deployment to time of hospital discharge
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of lesions treated
89.1
8.Secondary Outcome
Title Assisted Primary Patency
Hide Description Defined as vessel patency resulting from a procedure performed in the treated segment.
Time Frame 12 months
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Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
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Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
78.3
9.Secondary Outcome
Title Secondary Patency Rate
Hide Description Defined as vessel patency resulting from any procedure that restores patency.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
78.9
10.Secondary Outcome
Title Change in Quality of Life - Improvement in Rutherford Class by >= 1 Category
Hide Description Improvement in Rutherford class by ≥ 1 category increase at 12 months from pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).
Time Frame 12 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
90.9
11.Secondary Outcome
Title Change in Quality of Life - Increase in Ankle-brachial Index (ABI) or Toe-brachial Index (TBI) >= 0.15
Hide Description Increase in ABI/TBI ≥ 0.15 at 12 months from pre-procedure. An increase in ABI/TBI of 0.15 or greater is considered by clinicians to be a significant improvement.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
64.5
12.Secondary Outcome
Title Change in Quality of Life - Decrease in Rutherford Class >= 1 Category
Hide Description Decline in Rutherford class ≥ 1 category at 30 days when compared to pre-procedure according to the Rutherford Scale Classification. The Rutherford Classification is a categorical scale (0 - 6) used by clinicians to assess the degree of peripheral arterial disease in a person. The scale begins with 0 (no symptoms) and ends with 6 (worse case symptoms).
Time Frame 30 Days
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
89.7
13.Secondary Outcome
Title Percentage of Participants Free From Strut Fractures
Hide Description Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up.
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Overall Number of Units Analyzed
Type of Units Analyzed: Stents implanted with x-ray follow-up
189
Measure Type: Number
Unit of Measure: percentage of participants
100.0
14.Secondary Outcome
Title Clinically-driven Target Lesion Revascularization (TLR) Rate
Hide Description Defined as those revascularizations in which the subject has ischemic symptoms consistent with changes within the target lesion as demonstrated by: a change (decrease from post-procedure) in the Rutherford scale by at least one category, or a change (decrease from post-procedure) in ABI/TBI >= 0.15
Time Frame 12 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

Device: Complete SE Vascular Stent System >

> Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
8.4
15.Secondary Outcome
Title Major Adverse Event (MAE) Rate
Hide Description Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 24 month timepoint.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Complete SE Vascular Stent System
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COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.

Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
22.5
16.Secondary Outcome
Title Percentage of Participants Free From Strut Fractures
Hide Description Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 24 month timepoint.
Time Frame 24 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat (ITT)
Arm/Group Title Complete Self-expanding (SE) Vascular Stent System
Hide Arm/Group Description:

Device: Complete Self-expanding (SE) Vascular Stent System >

> Complete Self-expanding (SE) Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.

Overall Number of Participants Analyzed 196
Overall Number of Units Analyzed
Type of Units Analyzed: Stents implanted with x-ray follow-up
159
Measure Type: Number
Unit of Measure: percentage of participants
100.0
17.Secondary Outcome
Title Major Adverse Event (MAE) Rate
Hide Description Major Adverse Events (MAE) defined as device and/or procedure related death (or any death occurring post-procedure through Day 30), target limb loss and target lesion or target vessel revascularization at the 36 month timepoint.
Time Frame 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.

Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).

Overall Number of Participants Analyzed 196
Measure Type: Number
Unit of Measure: percentage of participants
30.2
18.Secondary Outcome
Title Percentage of Participants Free From Strut Fractures
Hide Description Defined as percent free from strut fractures. Percentage based on number of stents implanted with flat plate x-ray follow-up at the 36 month timepoint.
Time Frame 36 Months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-Treat
Arm/Group Title Complete SE Vascular Stent System
Hide Arm/Group Description:

COMPLETE SE Vascular Stent System - implantation of study device in native SFA and/or PPA for subjects with symptomatic ischemic peripheral arterial disease in the superficial femoral artery or proximal popliteal arteries with an occlusion or lesion greater or equal to 50 percent with lesions located above the knee and amenable to percutaneous treatment with angioplasty and vascular stent implantation.

Complete SE Vascular Stent System: Complete SE Vascular Stent System in the treatment of de novo and/or restenotic lesions or occlusions in the Superficial Femoral Artery (SFA) and/or the Proximal Popliteal Artery (PPA) in subjects with symptomatic Peripheral Artery Disease (PAD).

Overall Number of Participants Analyzed 196
Overall Number of Units Analyzed
Type of Units Analyzed: Stents implanted with x-ray follow-up
159
Measure Type: Number
Unit of Measure: percentage of participants
100.0
Time Frame 12 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1. Complete SE Vascular Stent System
Hide Arm/Group Description Complete SE Vascular Stent System: The Complete SE Vascular Stent System consists of a self-expanding stent and an over the wire (OTW) delivery system.
All-Cause Mortality
1. Complete SE Vascular Stent System
Affected / at Risk (%)
Total   --/--    
Hide Serious Adverse Events
1. Complete SE Vascular Stent System
Affected / at Risk (%) # Events
Total   117/196 (59.69%)    
Blood and lymphatic system disorders   
Anaemia  1  8/196 (4.08%)  9
Thrombocytopenia  1  1/196 (0.51%)  1
Cardiac disorders   
Acute Myocardial Infarction  1  4/196 (2.04%)  4
Angina Pectoris  1  4/196 (2.04%)  4
Angina Unstable  1  3/196 (1.53%)  3
Atrial Fibrillation  1  4/196 (2.04%)  4
Atrioventricular Block  1  1/196 (0.51%)  1
Bradycardia  1  1/196 (0.51%)  1
Cardiac Failure  1  3/196 (1.53%)  4
Cardiac Failure Congestive  1  3/196 (1.53%)  4
Coronary Artery Disease  1  10/196 (5.10%)  10
Myocardial Infarction  1  2/196 (1.02%)  2
Myocardial Ischaemia  1  1/196 (0.51%)  1
Sick Sinus Syndrome  1  2/196 (1.02%)  2
Ventricular Tachycardia  1  2/196 (1.02%)  2
Congenital, familial and genetic disorders   
Gastrointestinal Angiodysplasia  1  1/196 (0.51%)  1
Eye disorders   
Vitreous Haemorrhage  1  1/196 (0.51%)  1
Gastrointestinal disorders   
Abdominal Pain  1  1/196 (0.51%)  1
Abdominal Strangulated Hernia  1  1/196 (0.51%)  1
Ascites  1  1/196 (0.51%)  1
Colitis  1  1/196 (0.51%)  1
Duodenal Ulcer Perforation  1  1/196 (0.51%)  1
Gastrointestinal Haemorrhage  1  3/196 (1.53%)  3
Gastrooesophageal Reflux Disease  1  1/196 (0.51%)  1
Mesenteric Vein Thrombosis  1  1/196 (0.51%)  1
Pancreatitis Acute  1  2/196 (1.02%)  2
Small Intestinal Obstruction  1  2/196 (1.02%)  2
Vomiting  1  1/196 (0.51%)  1
General disorders   
Asthenia  1  1/196 (0.51%)  2
Catheter Site Haemorrhage  1  1/196 (0.51%)  1
Chest Pain  1  9/196 (4.59%)  9
Gait Disturbance  1  2/196 (1.02%)  2
Impaired Healing  1  2/196 (1.02%)  2
Non-Cardiac Chest Pain  1  1/196 (0.51%)  1
Pyrexia  1  1/196 (0.51%)  1
Vessel Puncture Site Haematoma  1  1/196 (0.51%)  1
Wound Necrosis  1  1/196 (0.51%)  1
Hepatobiliary disorders   
Bile Duct Stone  1  1/196 (0.51%)  2
Gallbladder Disorder  1  1/196 (0.51%)  1
Infections and infestations   
Bronchitis  1  4/196 (2.04%)  4
Bronchopneumonia  1  1/196 (0.51%)  1
Cellulitis  1  4/196 (2.04%)  5
Clostridium Difficile Colitis  1  1/196 (0.51%)  1
Diverticulitis  1  1/196 (0.51%)  1
Gangrene  1  1/196 (0.51%)  1
Infection  1  1/196 (0.51%)  1
Lobar Pneumonia  1  1/196 (0.51%)  1
Localised Infection  1  1/196 (0.51%)  1
Osteomyelitis  1  1/196 (0.51%)  1
Osteomyelitis Acute  1  1/196 (0.51%)  1
Pneumonia  1  5/196 (2.55%)  5
Sepsis  1  5/196 (2.55%)  5
Subcutaneous Abscess  1  1/196 (0.51%)  1
Urinary Tract Infection  1  2/196 (1.02%)  4
Wound Infection  1  1/196 (0.51%)  1
Injury, poisoning and procedural complications   
Device Electrical Finding  1  1/196 (0.51%)  1
Hip Fracture  1  1/196 (0.51%)  1
Humerus Fracture  1  1/196 (0.51%)  1
In-Stent Arterial Restenosis  1  14/196 (7.14%)  15
Pelvic Fracture  1  1/196 (0.51%)  1
Stent Occlusion  1  5/196 (2.55%)  5
Metabolism and nutrition disorders   
Diabetes Mellitus  1  1/196 (0.51%)  1
Failure To Thrive  1  1/196 (0.51%)  1
Gout  1  1/196 (0.51%)  1
Metabolic Acidosis  1  1/196 (0.51%)  1
Musculoskeletal and connective tissue disorders   
Back Pain  1  2/196 (1.02%)  3
Pain In Extremity  1  1/196 (0.51%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Lung Neoplasm Malignant  1  1/196 (0.51%)  1
Malignant Melanoma  1  1/196 (0.51%)  1
Neoplasm Malignant  1  1/196 (0.51%)  1
Prostate Cancer  1  1/196 (0.51%)  1
Nervous system disorders   
Carotid Artery Stenosis  1  7/196 (3.57%)  8
Cerebral Infarction  1  1/196 (0.51%)  1
Cerebrovascular Accident  1  2/196 (1.02%)  2
Dizziness  1  1/196 (0.51%)  2
Hemiparesis  1  1/196 (0.51%)  1
Presyncope  1  1/196 (0.51%)  1
Spinal Claudication  1  1/196 (0.51%)  1
Transient Ischaemic Attack  1  1/196 (0.51%)  1
Psychiatric disorders   
Alcohol Withdrawal Syndrome  1  1/196 (0.51%)  1
Depression  1  1/196 (0.51%)  1
Mental Status Changes  1  2/196 (1.02%)  2
Psychotic Disorder  1  1/196 (0.51%)  1
Renal and urinary disorders   
Renal Artery Stenosis  1  1/196 (0.51%)  1
Renal Failure Acute  1  4/196 (2.04%)  4
Respiratory, thoracic and mediastinal disorders   
Acute Respiratory Distress Syndrome  1  1/196 (0.51%)  1
Acute Respiratory Failure  1  1/196 (0.51%)  1
Chronic Obstructive Pulmonary Disease  1  2/196 (1.02%)  2
Dyspnoea  1  3/196 (1.53%)  3
Interstitial Lung Disease  1  1/196 (0.51%)  1
Pleural Effusion  1  1/196 (0.51%)  1
Pulmonary Embolism  1  2/196 (1.02%)  2
Respiratory Failure  1  1/196 (0.51%)  1
Skin and subcutaneous tissue disorders   
Decubitus Ulcer  1  1/196 (0.51%)  1
Skin Ulcer  1  1/196 (0.51%)  1
Surgical and medical procedures   
Hip Arthroplasty  1  1/196 (0.51%)  1
Peripheral Revascularisation  1  3/196 (1.53%)  3
Tendon Sheath Incision  1  1/196 (0.51%)  1
Wound Debridement  1  1/196 (0.51%)  1
Vascular disorders   
Aneurysm  1  1/196 (0.51%)  1
Arterial Occlusive Disease  1  2/196 (1.02%)  2
Arterial Restenosis  1  2/196 (1.02%)  2
Arterial Stenosis  1  1/196 (0.51%)  3
Arterial Stenosis Limb  1  5/196 (2.55%)  5
Artery Dissection  1  7/196 (3.57%)  7
Femoral Arterial Stenosis  1  16/196 (8.16%)  17
Femoral Artery Occlusion  1  3/196 (1.53%)  3
Haematoma  1  1/196 (0.51%)  1
Iliac Artery Stenosis  1  1/196 (0.51%)  1
Intermittent Claudication  1  13/196 (6.63%)  15
Peripheral Arterial Occlusive Disease  1  2/196 (1.02%)  2
Peripheral Artery Dissection  1  3/196 (1.53%)  3
Peripheral Embolism  1  1/196 (0.51%)  1
Peripheral Ischaemia  1  3/196 (1.53%)  3
Peripheral Vascular Disorder  1  1/196 (0.51%)  1
Vascular Pseudoaneurysm  1  1/196 (0.51%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1. Complete SE Vascular Stent System
Affected / at Risk (%) # Events
Total   50/196 (25.51%)    
General disorders   
Chest Pain  1  12/196 (6.12%)  13
Musculoskeletal and connective tissue disorders   
Back Pain  1  16/196 (8.16%)  16
Pain In Extremity  1  15/196 (7.65%)  18
Vascular disorders   
Intermittent Claudication  1  17/196 (8.67%)  17
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Arslan Malik - Senior Clinical Research Manager
Organization: Medtronic Aortic and Peripheral Vascular
Phone: (707) 541-3256
EMail: arslan.malik@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00814970    
Other Study ID Numbers: IP105
IDE G080143 ( Other Identifier: FDA )
First Submitted: December 23, 2008
First Posted: December 25, 2008
Results First Submitted: April 22, 2014
Results First Posted: May 21, 2014
Last Update Posted: April 13, 2016