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

NCT ID: NCT01263665

Last Updated: 2015-12-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 71 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-12-31
• Study Completion Date: 2015-11-30

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.

Conditions

Peripheral Vascular Diseases

Keywords

stent-graft; superficial femoral artery; SFA; peripheral artery disease; PAD

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

25cm Gore VIABAHN

25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface

Group Type: EXPERIMENTAL

25 cm GORE® VIABAHN®

Intervention Type: DEVICE

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).

Interventions

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).

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

W.L.Gore & Associates

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Zeller, Prof. Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Herzzentrum Bad Krozingen

References

Bohme T, Noory E, Brechtel K, Scheinert D, Bosiers M, Beschorner U, Zeller T. Heparin-Bonded Stent-Graft for the Treatment of TASC II C and D Femoropopliteal Lesions: 36-Month Results of the Viabahn 25 cm Trial. J Endovasc Ther. 2021 Apr;28(2):222-228. doi: 10.1177/1526602820965965. Epub 2020 Oct 12.

Reference Type: DERIVED

PMID: 33044119 (View on PubMed)

Zeller T, Peeters P, Bosiers M, Lammer J, Brechtel K, Scheinert D, Rastan A, Noory E, Beschorner U. Heparin-bonded stent-graft for the treatment of TASC II C and D femoropopliteal lesions: the Viabahn-25 cm trial. J Endovasc Ther. 2014 Dec;21(6):765-74. doi: 10.1583/14-4790R.1.

Reference Type: DERIVED

PMID: 25453876 (View on PubMed)

Other Identifiers

VBL 10-04

Identifier Type: -

Identifier Source: org_study_id