Clinical trial NCT01263665: Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peripheral Vascular Diseases
Keywords: stent-graft
superficial femoral artery
SFA
peripheral artery disease
PAD
Lead sponsor: W.L.Gore & Associates
Sponsor class: INDUSTRY
First posted: 2010-12-21
Enrollment: 71
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Successful Completion of the Assigned Treatment
timeFrame: Evaluated immediately after the index procedure
measure: Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure
timeFrame: 30 Days post-procedure
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Herzzentrum Bad Krozingen
name: Thomas Zeller, Prof. Dr. med.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.