Peripheral Arterial Occlusive Disease (PAOD)
Conditions
Brief summary
The purpose of the post-market study was to evaluate the safety and performance of the FUSION Vascular Graft.
Detailed description
This study was a prospective, single-arm, multicenter study conducted in Germany and Austria to evaluate the FUSION Vascular Graft in patients with peripheral arterial occlusive disease undergoing above-the-knee bypass. Follow-up visits were performed at 30 days, 6 months, 12 months and included patency and post operative complications not associated with bypass patency.
Interventions
DEVICEFUSION Vascular Graft
All subjects who received the FUSION Vascular Graft at the baseline implant procedure.
Sponsors
Maquet Cardiovascular
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Patients treated with the FUSION Vascular Graft
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* No known malignant disease * Patient was willing and able to have follow-up visits and examinations * Peripheral arterial occlusive disease (PAOD) requiring treatment of the femoral artery; Fontaine stage IIb, III and IV with dry peripheral gangrene, and suitable for surgery * Patient was not participating in other clinical trials that would conflict with this protocol * Patient agreed to the study provisions and provided written informed consent
Exclusion criteria
* Urgent or emergent surgery of any kind * Documented acute or suspected systemic infection * Life expectancy of less than one year * Patients who had a minor or major stroke within 6 weeks of the procedure or who had evidence of prior massive stroke * Patients who had experienced a myocardial infarction within 6 weeks prior to the procedure or had unstable angina pectoris * Severe chronic renal insufficiency or undergoing hemodialysis * Patients treated with coumadin (warfarin) that had not been stopped within 72 before enrollment * Medical conditions requiring oral anticoagulation * Antiplatelet therapy with clopidogrel or dual antiplatelet as well as any other antithrombotic medication within 7 days prior to scheduled bypass surgery except unfractionated heparin or aspirin * International normalized ratio (INR) \> 2.0 * Known hypersensitivity to heparin * Patient not tolerating aspirin * Previous history of bypass surgery in the target limb * Patient with category 6 ischemia (tissue loss) * Acute limb ischemia of any grade (0-3) * Patient with no outflow beyond the popliteal artery * Pregnant or may become pregnant during the course of the study * Uncontrolled arterial hypertension (BP \> 200 mmHg) at 2 successive readings * Anaemia (hemoglobin \< 8 g/ml) * Thrombocytopenia \< 50 g/L * Active bleeding according to clinical judgment * Infected wet gangrene of any size and location at the target limb * Compromised arterial flow * Patient unwilling or unable to comply with follow-up requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Primary Graft Patency at 12 Months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Secondary Graft Patency at 12 Months | 12 Months | 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. |
| Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months | 30 days, 6 months, 12 months | 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. |
| Rutherford Category at 30 Days, 6 Months and 12 Months | 30 days, 6 months, 12 months | 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). |
| Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death | 12 Months | 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. |
Countries
Austria, Germany
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| FUSION Vascular Graft All subjects who received a FUSION Vascular Graft at the baseline implant procedure | 117 |
| Total | 117 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 4 |
| Overall Study | Lost to Follow-up | 6 |
| Overall Study | Other: patient refusal to continue | 3 |
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | FUSION Vascular Graft |
|---|---|
| Age, Continuous | 67.8 years STANDARD_DEVIATION 8.85 |
| Ankle-brachial index | 0.53 ratio STANDARD_DEVIATION 0.196 |
| Body Mass Index (BMI) | 26.7 kg/m^2 STANDARD_DEVIATION 4.36 |
| Region of Enrollment Austria | 19 participants |
| Region of Enrollment Germany | 98 participants |
| Rutherford Category, No (%) Category 0, asymptomatic | 1 Participants |
| Rutherford Category, No (%) Category 1, mild claudication | 1 Participants |
| Rutherford Category, No (%) Category 2, moderate claudication | 55 Participants |
| Rutherford Category, No (%) Category 3, severe claudication | 42 Participants |
| Rutherford Category, No (%) Category 4, ischemic rest pain | 8 Participants |
| Rutherford Category, No (%) Category 5, minor tissue loss | 10 Participants |
| Rutherford Category, No (%) Category 6, major tissue loss | 0 Participants |
| Sex: Female, Male Female | 50 Participants |
| Sex: Female, Male Male | 67 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 117 |
| other Total, other adverse events | 0 / 117 |
| serious Total, serious adverse events | 48 / 117 |
Outcome results
Primary
Participants With Primary Graft Patency 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.
Time frame: 12 Months
Population: Analysis limited to participants who were known primary patency failures (i.e. interventions were documented) or had a patency assessment at 12 months.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FUSION Vascular Graft | Participants With Primary Graft Patency at 12 Months | 89 Participants |
Secondary
Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months
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.
Time frame: 30 days, 6 months, 12 months
Population: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| FUSION Vascular Graft | Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months | 6 months | 0.94 ratio | Standard Deviation 0.21 |
| FUSION Vascular Graft | Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months | 12 Months | 0.91 ratio | Standard Deviation 0.216 |
| FUSION Vascular Graft | Mean Ankle-brachial Index at 30 Days, 6 Months and 12 Months | 30 days | 0.97 ratio | Standard Deviation 0.157 |
Secondary
Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death
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.
Time frame: 12 Months
Population: All subjects who received a FUSION Vascular Graft at the baseline implant procedure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| FUSION Vascular Graft | Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death | Major amputation | 0 Participants |
| FUSION Vascular Graft | Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death | Major graft reintervention | 15 Participants |
| FUSION Vascular Graft | Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death | Any MALE or POD | 15 Participants |
| FUSION Vascular Graft | Number of Participants Experiencing Major Adverse Limb Events and Periprocedural Death | Procedure-related death | 0 Participants |
Secondary
Participants With Secondary Graft Patency at 12 Months
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.
Time frame: 12 Months
Population: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| FUSION Vascular Graft | Participants With Secondary Graft Patency at 12 Months | 96 Participants |
Secondary
Rutherford Category at 30 Days, 6 Months and 12 Months
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).
Time frame: 30 days, 6 months, 12 months
Population: 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.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 30 Days | Category 0, asymptomatic | 65 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 30 Days | Category 3, severe claudication | 3 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 30 Days | Category 4, ischemic rest paint | 0 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 30 Days | Category 5, minor tissue loss | 1 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 30 Days | Category 6, major tissue loss | 0 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 6 Months | Category 0, asymptomatic | 67 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 6 Months | Category 1, mild claudication | 23 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 6 Months | Category 2, moderate claudication | 3 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 6 Months | Category 3, severe claudication | 1 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 6 Months | Category 4, ischemic rest paint | 1 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 6 Months | Category 5, minor tissue loss | 2 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 12 Months | Category 1, mild claudication | 20 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 12 Months | Category 2, moderate claudication | 7 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 30 Days | Category 1, mild claudication | 30 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 30 Days | Category 2, moderate claudication | 8 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 6 Months | Category 6, major tissue loss | 0 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 12 Months | Category 0, asymptomatic | 68 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 12 Months | Category 3, severe claudication | 3 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 12 Months | Category 4, ischemic rest paint | 3 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 12 Months | Category 5, minor tissue loss | 1 Participants |
| FUSION Vascular Graft | Rutherford Category at 30 Days, 6 Months and 12 Months | 12 Months | Category 6, major tissue loss | 0 Participants |