Trial Outcomes & Findings for Evaluation of FUSION™ Vascular Graft for Above Knee Targets (NCT NCT01601496)
NCT ID: NCT01601496
Last Updated: 2020-10-14
Results Overview
Subjects were assessed to have had primary graft patency at 12 months. A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no interventions. Patency was assessed by duplex ultrasound imaging.
TERMINATED
NA
117 participants
12 Months
2020-10-14
Participant Flow
Subjects were referred to and treated at 10 vascular surgery centers in Germany and Austria. Enrolled subjects received a FUSION Vascular Graft between October 2009 and May 2012.
Patients were enrolled if they had peripheral artery occlusive disease (PAOD), signed informed consent forms, received subject numbers, and were screened for inclusion in the study. One subject failed to meet all eligibility criteria, prior to implantation of a FUSION vascular graft, and was not included in the efficacy or safety analyses.
Participant milestones
| Measure |
FUSION Vascular Graft
All subjects who received a FUSION Vascular Graft at the baseline implant procedure
|
|---|---|
|
Overall Study
STARTED
|
117
|
|
Overall Study
COMPLETED
|
102
|
|
Overall Study
NOT COMPLETED
|
15
|
Reasons for withdrawal
| Measure |
FUSION Vascular Graft
All subjects who received a FUSION Vascular Graft at the baseline implant procedure
|
|---|---|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Lost to Follow-up
|
6
|
|
Overall Study
Death
|
4
|
|
Overall Study
Other: patient refusal to continue
|
3
|
Baseline Characteristics
Patients with available measurement data for Ankle-brachial index.
Baseline characteristics by cohort
| Measure |
FUSION Vascular Graft
n=117 Participants
All subjects who received a FUSION Vascular Graft at the baseline implant procedure
|
|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 8.85 • n=117 Participants
|
|
Sex: Female, Male
Female
|
50 Participants
n=117 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=117 Participants
|
|
Region of Enrollment
Austria
|
19 participants
n=117 Participants
|
|
Region of Enrollment
Germany
|
98 participants
n=117 Participants
|
|
Body Mass Index (BMI)
|
26.7 kg/m^2
STANDARD_DEVIATION 4.36 • n=117 Participants
|
|
Ankle-brachial index
|
0.53 ratio
STANDARD_DEVIATION 0.196 • n=115 Participants • Patients with available measurement data for Ankle-brachial index.
|
|
Rutherford Category, No (%)
Category 0, asymptomatic
|
1 Participants
n=117 Participants
|
|
Rutherford Category, No (%)
Category 1, mild claudication
|
1 Participants
n=117 Participants
|
|
Rutherford Category, No (%)
Category 2, moderate claudication
|
55 Participants
n=117 Participants
|
|
Rutherford Category, No (%)
Category 3, severe claudication
|
42 Participants
n=117 Participants
|
|
Rutherford Category, No (%)
Category 4, ischemic rest pain
|
8 Participants
n=117 Participants
|
|
Rutherford Category, No (%)
Category 5, minor tissue loss
|
10 Participants
n=117 Participants
|
|
Rutherford Category, No (%)
Category 6, major tissue loss
|
0 Participants
n=117 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: Analysis limited to participants who were known primary patency failures (i.e. interventions were documented) or had a patency assessment at 12 months.
Subjects were assessed to have had primary graft patency at 12 months. A graft was considered to have primary patency if it had remained continuously patent (i.e., had continued blood flow through it) from the time of implantation and it had uninterrupted patency with no interventions. Patency was assessed by duplex ultrasound imaging.
Outcome measures
| Measure |
FUSION Vascular Graft
n=104 Participants
All subjects who received a FUSION Vascular Graft at the baseline implant procedure
|
|---|---|
|
Participants With Primary Graft Patency at 12 Months
|
89 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: Analysis limited to participants who had a patency assessment at 12 months or had been a secondary graft patency failure at a prior visit without restoration of flow.
Subjects were assessed to have had secondary graft patency at 12 months. Secondary graft patency was defined as a graft patency established by another intervention to remediate occlusion within 12 months after surgery.
Outcome measures
| Measure |
FUSION Vascular Graft
n=103 Participants
All subjects who received a FUSION Vascular Graft at the baseline implant procedure
|
|---|---|
|
Participants With Secondary Graft Patency at 12 Months
|
96 Participants
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: Patients with available ankle-brachial index measurements at the individual time point. Note that the number of patients with an ankle-brachial index measurement varies by time point.
Ankle-brachial index at 30 days, 6 months, and 12 months. The ankle-brachial index is the ratio between the systolic pressure measured at the ankle and the systolic pressure measured in the arm.
Outcome measures
| Measure |
FUSION Vascular Graft
n=117 Participants
All subjects who received a FUSION Vascular Graft at the baseline implant procedure
|
|---|---|
|
Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months
30 days
|
0.97 ratio
Standard Deviation 0.157
|
|
Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months
6 months
|
0.94 ratio
Standard Deviation 0.210
|
|
Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months
12 Months
|
0.91 ratio
Standard Deviation 0.216
|
SECONDARY outcome
Timeframe: 30 days, 6 months, 12 monthsPopulation: Patients with available Rutherford classification at the individual time point. Note that the number of patients with an assigned Rutherford classification varies by time point.
Rutherford category at 30 days, 6 months and 12 months. Rutherford classification is a staging system to describe lower extremity ischemia, and is assigned by the Investigator. Higher grades represent more severe disease, ranging from asymptomatic (category 0) to major tissue loss (category 6).
Outcome measures
| Measure |
FUSION Vascular Graft
n=117 Participants
All subjects who received a FUSION Vascular Graft at the baseline implant procedure
|
|---|---|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
30 Days · Category 3, severe claudication
|
3 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
30 Days · Category 4, ischemic rest paint
|
0 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
30 Days · Category 5, minor tissue loss
|
1 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
30 Days · Category 6, major tissue loss
|
0 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
6 Months · Category 0, asymptomatic
|
67 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
6 Months · Category 1, mild claudication
|
23 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
6 Months · Category 2, moderate claudication
|
3 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
6 Months · Category 3, severe claudication
|
1 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
6 Months · Category 4, ischemic rest paint
|
1 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
6 Months · Category 5, minor tissue loss
|
2 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
6 Months · Category 6, major tissue loss
|
0 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
12 Months · Category 0, asymptomatic
|
68 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
12 Months · Category 1, mild claudication
|
20 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
12 Months · Category 2, moderate claudication
|
7 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
12 Months · Category 3, severe claudication
|
3 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
12 Months · Category 4, ischemic rest paint
|
3 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
12 Months · Category 5, minor tissue loss
|
1 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
12 Months · Category 6, major tissue loss
|
0 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
30 Days · Category 0, asymptomatic
|
65 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
30 Days · Category 1, mild claudication
|
30 Participants
|
|
Rutherford Category at 30 Days, 6 Months and 12 Months
30 Days · Category 2, moderate claudication
|
8 Participants
|
SECONDARY outcome
Timeframe: 12 MonthsPopulation: All subjects who received a FUSION Vascular Graft at the baseline implant procedure.
Major Adverse Limb Events (MALE) were defined as major amputation (any amputation that resulted in limb shortening) or major graft reintervention (including placement of a new bypass graft at the same anatomic site, a jump/interposition graft, graft thrombectomy, graft excision (explant), or graft thrombolysis). Periprocedural Death (POD) was defined as death within 30 days of the index procedure or within 30 days of any remedial procedure performed at the same anatomical site or as a result of the initial procedure.
Outcome measures
| Measure |
FUSION Vascular Graft
n=117 Participants
All subjects who received a FUSION Vascular Graft at the baseline implant procedure
|
|---|---|
|
Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death
Major amputation
|
0 Participants
|
|
Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death
Procedure-related death
|
0 Participants
|
|
Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death
Major graft reintervention
|
15 Participants
|
|
Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death
Any MALE or POD
|
15 Participants
|
Adverse Events
FUSION Vascular Graft
Serious adverse events
| Measure |
FUSION Vascular Graft
n=117 participants at risk
All subjects who receive a FUSION Vascular Graft at the baseline implant procedure
|
|---|---|
|
Cardiac disorders
Cardiac Failure
|
0.85%
1/117 • Number of events 2 • Through 12 months follow up
|
|
Gastrointestinal disorders
Gallstone ileus
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Gastrointestinal disorders
Ileal stenosis
|
1.7%
2/117 • Number of events 3 • Through 12 months follow up
|
|
General disorders
Death
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
General disorders
Impaired healing
|
1.7%
2/117 • Number of events 2 • Through 12 months follow up
|
|
General disorders
Oedema peripheral
|
1.7%
2/117 • Number of events 2 • Through 12 months follow up
|
|
Renal and urinary disorders
Renal failure
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Infections and infestations
Graft infection
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Infections and infestations
Infection
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Infections and infestations
Pneumonia
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Infections and infestations
Wound infection
|
6.8%
8/117 • Number of events 8 • Through 12 months follow up
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Injury, poisoning and procedural complications
Seroma
|
2.6%
3/117 • Number of events 3 • Through 12 months follow up
|
|
Injury, poisoning and procedural complications
Transplant failure
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Injury, poisoning and procedural complications
Vascular graft occlusion
|
12.8%
15/117 • Number of events 24 • Through 12 months follow up
|
|
Injury, poisoning and procedural complications
Wound secretion
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bronchial carcinoma
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Surgical and medical procedures
Angioplasty
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Surgical and medical procedures
Aortic aneurysm repair
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Surgical and medical procedures
Peripheral endarterectomy
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Surgical and medical procedures
Surgery
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Vascular disorders
Aortic stenosis
|
1.7%
2/117 • Number of events 3 • Through 12 months follow up
|
|
Vascular disorders
Intermittent claudication
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Vascular disorders
Haematoma
|
3.4%
4/117 • Number of events 4 • Through 12 months follow up
|
|
Vascular disorders
Leriche syndrome
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
|
Vascular disorders
Peripheral ischemia
|
1.7%
2/117 • Number of events 2 • Through 12 months follow up
|
|
Vascular disorders
Vasculitis
|
0.85%
1/117 • Number of events 1 • Through 12 months follow up
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place