Trial Outcomes & Findings for Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis (NCT NCT01263665)
NCT ID: NCT01263665
Last Updated: 2015-12-17
Results Overview
Successful completion of the assigned treatment and postdeployment\> stent length (of the first deployed 25 cm GORE\> VIABAHN Endoprosthesis with PROPATEN Bioactive Surface)\> being within 10% of pre-deployment stent length.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
71 participants
Primary outcome timeframe
Evaluated immediately after the index procedure
Results posted on
2015-12-17
Participant Flow
Participant milestones
| Measure |
25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac
25 cm length GORE® VIABAHN® Endoprosthesis with
\> PROPATEN Bioactive Surface Subjects
|
|---|---|
|
Overall Study
STARTED
|
71
|
|
Overall Study
COMPLETED
|
62
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac
25 cm length GORE® VIABAHN® Endoprosthesis with
\> PROPATEN Bioactive Surface Subjects
|
|---|---|
|
Overall Study
Withdrew Consent
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Amputation above the ankle
|
1
|
|
Overall Study
Surgical Bypass
|
2
|
Baseline Characteristics
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
Baseline characteristics by cohort
| Measure |
Investigational Arm
n=71 Participants
25 cm length GORE® VIABAHN® Endoprosthesis with\> PROPATEN Bioactive Surface Subjects
|
|---|---|
|
Age, Continuous
|
66.7 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
51 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
17 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Evaluated immediately after the index procedureSuccessful completion of the assigned treatment and postdeployment\> stent length (of the first deployed 25 cm GORE\> VIABAHN Endoprosthesis with PROPATEN Bioactive Surface)\> being within 10% of pre-deployment stent length.
Outcome measures
| Measure |
25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac
n=71 Participants
25 cm length GORE® VIABAHN® Endoprosthesis with\> PROPATEN Bioactive Surface Subjects
|
|---|---|
|
Successful Completion of the Assigned Treatment
|
76.7 percentage of subjects
|
PRIMARY outcome
Timeframe: 30 Days post-procedureOutcome measures
| Measure |
25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac
n=71 Participants
25 cm length GORE® VIABAHN® Endoprosthesis with\> PROPATEN Bioactive Surface Subjects
|
|---|---|
|
Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure
|
2 participants
|
Adverse Events
25 cm GORE VIABAHN
Serious events: 39 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
25 cm GORE VIABAHN
n=71 participants at risk
25 cm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
|
|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Cardiac disorders
Angina pectoris
|
4.2%
3/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Cardiac disorders
Angina unstable
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Cardiac disorders
Atrial fibrillation
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Cardiac disorders
Cardiac failure
|
4.2%
3/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Cardiac disorders
Coronary artery disease
|
2.8%
2/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Cardiac disorders
Coronary artery occlusion
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
General disorders
Impaired healing
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
General disorders
Inflammation
|
4.2%
3/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
General disorders
Pyrexia
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
General disorders
Thrombosis in device
|
23.9%
17/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Infections and infestations
Gangrene
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Infections and infestations
Infection
|
4.2%
3/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Infections and infestations
Influenza
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Injury, poisoning and procedural complications
Arterial injury
|
2.8%
2/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Injury, poisoning and procedural complications
Contrast media reaction
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
12.7%
9/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Investigations
C-reactive protein increased
|
2.8%
2/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Nervous system disorders
Monoparesis
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
2.8%
2/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Skin and subcutaneous tissue disorders
Diabetic neuropathic ulcer
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Vascular disorders
Aortic aneurysm
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Vascular disorders
Femoral arterial stenosis
|
14.1%
10/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Vascular disorders
Femoral artery occlusion
|
5.6%
4/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Vascular disorders
Intermittent claudication
|
2.8%
2/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
5.6%
4/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Vascular disorders
Peripheral ischaemia
|
1.4%
1/71 • Total through 2 years, data pulled as of 10Oct2014
|
Other adverse events
| Measure |
25 cm GORE VIABAHN
n=71 participants at risk
25 cm GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface
|
|---|---|
|
General disorders
Oedema peripheral
|
9.9%
7/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
General disorders
Vessel puncture site haematoma
|
2.8%
2/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Injury, poisoning and procedural complications
In-stent arterial restenosis
|
22.5%
16/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Investigations
C-reactive protein increased
|
5.6%
4/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.2%
3/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.0%
5/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Nervous system disorders
Hypoaesthesia
|
2.8%
2/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
2.8%
2/71 • Total through 2 years, data pulled as of 10Oct2014
|
|
Vascular disorders
Iliac artery stenosis
|
4.2%
3/71 • Total through 2 years, data pulled as of 10Oct2014
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Before the single-center publication is submitted or presented, the\> Investigator will provide a copy to the Sponsor and allow the Sponsor 30 days to review and\> comment. The Sponsor will review the publication for data accuracy only and not the\> conclusions or interpretations. If the Sponsor requests, the publication will be delayed an\> additional ninety (90) days, to allow Sponsor to ensure the protection of inventions or other\> property of Sponsor.
- Publication restrictions are in place
Restriction type: OTHER