Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis

Peripheral Vascular Diseases Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01263665
• Other study ID #: VBL 10-04
• Status: Completed
• Phase: N/A
• First received: December 8, 2010
• Last updated: November 18, 2015
• Start date: December 2010
• Est. completion date: November 2015

Study information

• Verified date: November 2015
• Source: W.L.Gore & Associates
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics CommissionBelgium: Ethics CommitteeAustria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: November 2015
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• 25 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
W.L.Gore & Associates

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Evaluated immediately after the index procedure	No
Primary	Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure		30 Days post-procedure	Yes