- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01263665
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
November 18, 2015 updated by: W.L.Gore & Associates
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)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
71
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 25cm Gore VIABAHN
25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Successful Completion of the Assigned Treatment
Time Frame: Evaluated immediately after the index procedure
|
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
Time Frame: 30 Days post-procedure
|
30 Days post-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thomas Zeller, Prof. Dr. med., Herzzentrum Bad Krozingen
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2010
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
November 1, 2015
Study Registration Dates
First Submitted
December 8, 2010
First Submitted That Met QC Criteria
December 20, 2010
First Posted (Estimate)
December 21, 2010
Study Record Updates
Last Update Posted (Estimate)
December 17, 2015
Last Update Submitted That Met QC Criteria
November 18, 2015
Last Verified
November 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VBL 10-04
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Vascular Diseases
-
C. R. BardCromsourceCompletedVascular Diseases, PeripheralGermany, Poland
-
Stanford UniversityTerminatedPAD - Peripheral Arterial Disease | PVD- Peripheral Vascular DiseaseUnited States
-
Alucent BiomedicalCompletedPeripheral Arterial Disease | Peripheral Vascular Diseases | Catheterization, PeripheralUnited States
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Peripheral Artery Occlusive DiseaseUnited States
-
SensomeRecruitingPeripheral Vascular DiseaseBelgium
-
Biotronik, Inc.CompletedPeripheral Vascular Disease | Peripheral Artery DiseaseCanada, United States
-
Biotronik AGBiotronik, Inc.UnknownPeripheral Vascular Disease | Peripheral Artery DiseaseGermany, Belgium, Austria, Switzerland
-
Baylor UniversityNational Institute on Aging (NIA)RecruitingArterial Occlusive Diseases | Peripheral Arterial Disease | Atherosclerosis | Vascular Diseases, PeripheralUnited States
-
Acotec Scientific Co., LtdRecruitingPeripheral Arterial Disease (PAD) | Peripheral Vascular Disease (PVD)China
-
Alucent BiomedicalCompletedPeripheral Arterial Disease | Peripheral Vascular Diseases | Catheterization, PeripheralUnited States
Clinical Trials on 25 cm GORE® VIABAHN®
-
W.L.Gore & AssociatesTerminatedPopliteal Artery AneurysmUnited States
-
W.L.Gore & AssociatesCompletedIatrogenic Vessel Injury
-
W.L.Gore & AssociatesCompletedPeripheral Arterial DiseaseJapan
-
W.L.Gore & AssociatesCompletedEvaluation of the GORE® VIABAHN® Endoprosthesis for the Treatment of Popliteal Artery Aneurysm (PAA)Popliteal Artery AneurysmFrance
-
W.L.Gore & AssociatesCompleted
-
Asociacion para el Estudio de la Enfermedades Vasculares...W.L.Gore & AssociatesUnknown
-
W.L.Gore & AssociatesRecruitingThoracic Aortic Aneurysm | Abdominal Aortic AneurysmSpain, Denmark, Italy, Norway, Netherlands, Sweden
-
W.L.Gore & AssociatesRecruitingTrauma Injury | Peripheral Artery Disease | Hemodialysis Access | Popliteal Aneurysm | Visceral Artery AneurysmsSpain, Italy, Germany, Sweden, Netherlands, United Kingdom, France, Belgium, Greece
-
Flanders Medical Research ProgramCompletedPeripheral Vascular DiseaseBelgium, Germany
-
American Access CareUnknownHemodialysisUnited States