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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
W.L.Gore & Associates
ClinicalTrials.gov Identifier:
NCT01263665
First received: December 8, 2010
Last updated: January 13, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Peripheral Vascular Diseases
Device: 25 cm GORE® VIABAHN®

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by W.L.Gore & Associates:

Primary Outcome Measures:
  • Successful Completion of the Assigned Treatment [ Time Frame: Evaluated immediately after the index procedure ] [ Designated as safety issue: No ]

    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 [ Time Frame: 30 Days post-procedure ] [ Designated as safety issue: Yes ]

Enrollment: 71
Study Start Date: December 2010
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 25cm Gore VIABAHN
25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface
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).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01263665

Sponsors and Collaborators
W.L.Gore & Associates
Investigators
Principal Investigator: Thomas Zeller, Prof. Dr. med. Herzzentrum Bad Krozingen
  More Information

No publications provided

Responsible Party: W.L.Gore & Associates
ClinicalTrials.gov Identifier: NCT01263665     History of Changes
Other Study ID Numbers: VBL 10-04
Study First Received: December 8, 2010
Results First Received: January 13, 2014
Last Updated: January 13, 2014
Health Authority: Germany: Ethics Commission
Belgium: Ethics Committee
Austria: Ethikkommission

Keywords provided by W.L.Gore & Associates:
stent-graft
superficial femoral artery
SFA
peripheral artery disease
PAD

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on April 17, 2014