Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
This trial is active, not recruiting.
|Condition||peripheral vascular diseases|
|Treatment||25 cm gore® viabahn®|
|Sponsor||W.L.Gore & Associates|
|Start date||December 2010|
|End date||September 2012|
|Trial size||71 participants|
|Trial identifier||NCT01263665, VBL 10-04|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||single group assignment|
Successful Completion of the Assigned Treatment
time frame: Evaluated immediately after the index procedure
Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure
time frame: 30 Days post-procedure
Male or female participants at least 21 years old.
- 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.
- 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.
- 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.
|Official title||Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface to Treat de Novo and/or Restenotic Lesions of the Superficial Femoral Artery (SFA)|
|Principal investigator||Thomas Zeller, Prof. Dr. med.|
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