Peripheral Vascular Diseases
Conditions
Keywords
stent-graft, superficial femoral artery, SFA, peripheral artery disease, PAD
Brief summary
The purpose of this study is to confirm the safety and performance of the 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface when used in the Superficial Femoral Artery.
Interventions
DEVICE25 cm GORE® VIABAHN®
25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface, possibly in conjunction with an additional overlapping VIABAHN® device (2.5, 5, 10, 15, or 25 cm lengths) based on the enrolled patient's lesion length (greater than or equal to 20 cm length).
Sponsors
W.L.Gore & Associates
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Lifestyle-limiting claudication or rest pain (meeting angiographic entry criteria) affecting a lower extremity (Rutherford Categories 2-4). * A written informed consent form, which has been reviewed and approved by the Ethics Committee, has been read, understood and signed by the subject (or their legally authorized representative). * At least 21 years of age. * Noninvasive lower extremity arterial studies (ankle-brachial index, ABI) prior to (within 45 days) or at the time of the study procedure demonstrating a resting ankle-brachial index (ABI) ≤ 0.9 in the study limb. If ABI \> 0.9, patient is eligible for study if toe-brachial index (TBI) is ≤ 0.5. * A staged ipsilateral vascular procedure was not completed less than 30-days prior to the study procedure. Resting ABIs were completed prior to the study procedure a minimum of 30-days after the staged vascular procedure. * Vascular treatment on the non-study leg for bilateral claudication was not performed less than 30-days prior to study procedure. Resting ABIs on the study limb were completed prior to the study procedure a minimum of 30-days after treatment on the non-study leg. * Male, infertile female, or female of child bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7-days prior to study procedure. * Projected life expectancy of greater than three years. * The ability to comply with protocol follow-up requirements and required testing. * Angiographic and Lesion Requirements (assessed intraoperatively): * Lesion length of 20-35 cm located in the region beginning 1 cm below origin of the profunda femoris artery and ending 1 cm above the origin of the intercondylar fossa. * De novo, post-percutaneous transluminal angioplasty (PTA), or post-atherectomy stenosis (\> 50% at some point within the lesion by visual estimate) or occlusion of native SFA. * Origin and proximal 1 cm of SFA are patent. * Popliteal artery is patent from 1 cm above the origin of the intercondylar fossa distal to the radiographic knee joint. * Reference vessel diameter of 4.0 - 7.5 mm in proximal and distal treatment segments within the SFA. * Angiographic evidence of at least one patent tibial artery to the ankle that does not require intervention. * Guidewire has successfully traversed lesion and is within the true lumen of the distal vessel.
Exclusion criteria
* Untreated flow-limiting aortoiliac occlusive disease. * Any previous open surgical procedure in the target vessel or previous stent placement in the target vessel. * Prior angioplasty on the target lesion performed less than 30 days prior to the study procedure (unless performed at time of the study procedure). * Prior atherectomy on the target lesion performed less than 6 months prior to the study procedure (unless performed at time of the study procedure). * Any previous treatment of the target vessel with a drug-eluting balloon. * Femoral artery or popliteal artery aneurysm. * Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis). * Tibial artery disease requiring treatment. * Prior ipsilateral femoral artery bypass. * Severe medical comorbidities (untreated coronary artery disease, congestive heart failure, severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would preclude post-procedural ambulation. * Popliteal artery vascular access at any time during procedure. * Antegrade and retrograde vascular access on the same common femoral artery at the time of the SFA intervention. * Major distal amputation (above the transmetatarsal) in the study or non-study limb. * Septicemia. * Any previously known coagulation disorder, including hypercoagulability. * Morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion). * Contraindication to anticoagulation or antiplatelet therapy. * Known allergies to stent/stent-graft components, including heparin sensitivity, allergy, or previous incidence of heparin-induced thrombocytopenia (HIT) type II. * History of prior life-threatening reaction to contrast agent. * Currently participating in another clinical research trial, unless approved by W. L. Gore & Associates in advance of study enrollment. * Subject has one limb currently enrolled in the study. * Current peritoneal or hemodialysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Successful Completion of the Assigned Treatment | Evaluated immediately after the index procedure | 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. |
| Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure | 30 Days post-procedure | — |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Investigational Arm 25 cm length GORE® VIABAHN® Endoprosthesis with\> PROPATEN Bioactive Surface Subjects | 71 |
| Total | 71 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Amputation above the ankle | 1 |
| Overall Study | Death | 2 |
| Overall Study | Lost to Follow-up | 3 |
| Overall Study | Surgical Bypass | 2 |
| Overall Study | Withdrew Consent | 1 |
Baseline characteristics
| Characteristic | Investigational Arm |
|---|---|
| Age, Continuous | 66.7 years |
| Region of Enrollment Austria | 3 participants |
| Region of Enrollment Belgium | 17 participants |
| Region of Enrollment Germany | 51 participants |
| Sex: Female, Male Female | 21 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 20 / 71 |
| serious Total, serious adverse events | 39 / 71 |
Outcome results
Primary
Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure
Time frame: 30 Days post-procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac | Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure | 2 participants |
Primary
Successful Completion of the Assigned Treatment
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.
Time frame: Evaluated immediately after the index procedure
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 25 cm Length GORE® VIABAHN® Endoprosthesis With PROPATEN Bioac | Successful Completion of the Assigned Treatment | 76.7 percentage of subjects |