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

NCT01263665 | Completed Results

• 1 other identifier: VBL 10-04
• Study Type: interventional
• Target: 71
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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

• Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure

  30 Days post-procedure

Study Arms (1)

25cm Gore VIABAHN

EXPERIMENTAL

25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface

Device: 25 cm GORE® VIABAHN®

Interventions

25 cm GORE® VIABAHN® 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).

25cm Gore VIABAHN

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• W.L.Gore & Associates: lead

Related Publications (2)

• 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.

  PMID: 33044119 DERIVED

• 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.

  PMID: 25453876 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases; Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases

Results Point of Contact

• Title: Keli Sapp
• Organization: W.L. Gore & Associates

kesapp@wlgore.com

9288643964

Study Officials

• Thomas Zeller, Prof. Dr. med.

  Herzzentrum Bad Krozingen

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2010
• First Posted: December 21, 2010
• Study Start: December 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: November 1, 2015
• Last Updated: December 17, 2015
• Results First Posted: February 24, 2014

Record last verified: 2015-11