Peripheral Vascular DiseasesNCT01263665
Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis
A study testing 25 cm GORE® VIABAHN® in people with Peripheral Vascular Diseases, run by W.L.Gore & Associates.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- 25 cm GORE® VIABAHN®
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- No sites listed yet
- Study dates
- Dec 2010to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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)
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
- Being tested
- 25 cm GORE® VIABAHN®
- Keywords
- stent-graft, superficial femoral artery, SFA, peripheral artery disease, PAD
- Medical subject headings
- Peripheral Vascular Diseases, Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| 25cm Gore VIABAHN | Experimental | 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface Receives: Device: 25 cm GORE® VIABAHN® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Evaluated immediately after the index procedure
Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure
Measured: 30 Days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionAug 2012
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by W.L.Gore & AssociatesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- W.L.Gore & Associates
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Zeller, Prof. Dr. med., Principal investigator, Herzzentrum Bad Krozingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01263665
- Sponsor's protocol ID
- VBL 10-04
- Status last verified
- Nov 2015
- First submitted
- 8 Dec 2010
- Last updated
- 17 Dec 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 33044119Zeller 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.
PubMed 25453876
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01263665
- Acronym / sponsor ID
- VBL 10-04
- Conditions
- Peripheral Vascular Diseases
- Keywords
- stent-graft, superficial femoral artery, SFA, peripheral artery disease, PAD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- W.L.Gore & AssociatesIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 21 Dec 2010 (estimated)
- Results
- Posted 24 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 25cm Gore VIABAHN | Experimental | Device: 25 cm GORE® VIABAHN®25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Device | 25cm Gore VIABAHN |
Primary outcome
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.
Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure
Time frame: 30 Days post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 33044119Bohme 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.
- Derived from this study: PubMed 25453876Zeller 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Zeller, Prof. Dr. med. principal investigator
Herzzentrum Bad Krozingen
Questions about this trial
What is this clinical trial studying?
A study testing 25 cm GORE® VIABAHN® in people with Peripheral Vascular Diseases, run by W.L.Gore & Associates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Completion of the Assigned Treatment (time frame: Evaluated immediately after the index procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01263665, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2015.