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Peripheral Vascular DiseasePhase 4RELINENCT01108861

GORE VIABAHN® Versus Plain Old Balloon Angioplasty (POBA) for Superficial Femoral Artery (SFA) In-Stent Restenosis

A Phase 4 study testing GORE VIABAHN® Endoprosthesis and Plain old balloon angioplasty in people with Peripheral Vascular Disease, run by Flanders Medical Research Program at 6 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a prospective, randomized, multi-center study recruiting patients with an in-stent restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn endoprosthesis (W.L. Gore \& Associates), a heparin-bonded endoprosthesis, is compared with plain old balloon angioplasty (POBA). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Vascular Disease
What is being tested?
GORE VIABAHN® Endoprosthesis and Plain old balloon angioplasty
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
6 sitesin 2 countries
Study dates
May 2010to Mar 2014
Phase
Phase 4
Are there results?
None posted in the registry

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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Untreated flow-limiting aortoiliac stenotic disease
  • Presence of a chronic total occlusion, i.e. a complete occlusion of the failed bare stent that cannot be re-opened with thrombolysis or does not allow easy passage of the guidewire by the physician
  • Any previous surgery in the target vessel
  • Severe ipsilateral common/deep femoral disease requiring surgical reintervention
  • Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
  • Femoral or popliteal aneurysm located at the target vessel
Show all 22Show fewer
  • Non-atherosclerotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
  • No patent tibial arteries (>50% stenosis)
  • Prior ipsilateral femoral artery bypass
  • Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancy, dementia, etc) or other medical condition that would preclude compliance with the study protocol or 2-year life expectancy
  • Serum creatinine >2.5mg/dL within 45 days prior to study procedure unless the subject is currently on dialysis
  • Major distal amputation (above the transmetatarsal) in the study or non-study limb
  • Septicemia or bacteremia
  • Any previously known coagulation disorder, including hypercoagulability
  • Contraindication to anticoagulation or antiplatelet therapy
  • Known allergies to stent or stent graft components (nickel-titanium or ePTFE)
  • Known allergy to contrast media that cannot be adequately pre-medicated prior to the study procedure
  • Patient with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
  • Currently participating in another clinical research trial, unless approved by W.L. Gore \& Associates in advance of study enrolment
  • Angiographic evidence of intra-arterial thrombus or atheroembolism from inflow treatment
  • Any planned surgical intervention/procedure within 30 days of the study procedure
  • Target lesion access not performed by transfemoral approach.

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

Belgium4 sites

  • Imelda Hospital

    Bonheiden, 2820

  • AZ Sint-Blasius

    Dendermonde, 9200

  • Universitair ziekenhuis antwerpen

    Edegem, 2650

  • Zuid Oost Limburg

    Genk, 3600

Other trials in Belgium

Germany2 sites

  • Herz-zentrum Bad Krozingen

    Bad Krozingen, 79189

  • Herzzentrum

    Leipzig, 04289

Other trials in Germany

About this study

Official title: The GORE VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface Versus Plain Old Balloon Angioplasty (POBA) for the Treatment of Superficial Femoral Artery (SFA) In-Stent Restenosis

This is a prospective, randomized, multi-center study recruiting patients with an in-stent restenosis in the superficial femoral artery. The safety and efficacity of the Viabahn endoprosthesis (W.L. Gore \& Associates), a heparin-bonded endoprosthesis, is compared with plain old balloon angioplasty (POBA). In 4 Belgian and 2 German centers a total of 80 Patients will be recruited. Primary endpoint is primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) measuring a peak systolic velocity ratio ≤2.5, and without target lesion revascularization (TLR) within 12 months.

In comparison to POBA, it is expected that the use of the Viabahn endoprosthesis (W.L. Gore \& Associates) will result in greater 12 month primary patency of treated superficial femoral artery in-stent restenotic lesions.

Being tested
GORE VIABAHN® Endoprosthesis, Plain old balloon angioplasty
Keywords
Peripheral Vascular Disease, In-stent restenosis, Endoprosthesis, Plain old balloon angioplasty
Medical subject headings
Peripheral Vascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GORE VIABAHN® EndoprosthesisDevice

    GORE VIABAHN® Endoprosthesis

  • Plain old balloon angioplastyDevice

    Plain old balloon angioplasty

Study groups in NCT01108861
Study groupRoleWhat they receive
EndoprosthesisExperimentalGORE VIABAHN® Endoprosthesis
Receives: Device: GORE VIABAHN® Endoprosthesis
Plain old balloon angioplastyActive comparatorPlain old balloon angioplasty
Receives: Device: Plain old balloon angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) and without target lesion revascularization (TLR) within 12 months.

    Measured: 1 year

  2. Proportion of subjects who experience serious device-related adverse events within 30 days post-procedure

    Measured: 30 days

Secondary outcomes (9)

  1. Technical success, defined as the ability to cross and dilate the lesion to achieve residual angiographic stenosis no greater than 30%.

    Measured: during procedure

  2. Hemodynamic primary patency rate at 1, 6, 12, 24-month follow-up.

    Patients that present without a hemodynamically significant stenosis at the target area on duplex ultrasound (systolic velocity ratio no greater than 2.5) and without prior TLR are defined as being primary patent at the given follow-up.

    Measured: 1, 6, 12, 24-month follow-up

  3. Angiographic primary patency at 12 months

    Angiographic primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on no Quantitative Angiographic evidence of stenosis > 50%

    Measured: 1 year

  4. Primary assisted patency rate at 1, 6, 12, 24-month follow-up.

    Primary assisted patency rate at 1, 6, 12, 24-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention completed prior to complete vessel closure.

    Measured: 1, 6, 12, 24-month follow-up

  5. Secondary patency rate at 1, 6, 12, 24-month follow-up

    Secondary patency rate at 1, 6, 12, 24-month follow-up. Defined as flow through the treated lesion maintained by repeat percutaneous intervention after occlusion of the target lesion.

    Measured: 1, 6, 12, 24-month follow-up

  6. Target lesion revascularization (TLR)

    Target lesion revascularization (TLR) is defined as a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5 mm proximal and distal to the device/PTA edge

    Measured: entire follow-up

  7. Clinical success at follow-up

    Clinical success at follow-up is defined as an improvement of Rutherford classification at 1 day and 1, 6, 12, 24-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.

    Measured: at 1 day and 1, 6, 12, 24-month follow-up

  8. Serious adverse events

    Serious adverse events as defined as any clinical event that is fatal, life-threatening, results in persistent or significant disability/incapacity, requires in-patient hospitalization or unduly prolonged hospitalization, necessitates an intervention to prevent a permanent impairment of a body function or permanent damage to a body structure, is a congenital abnormality/birth defect, a fetal distress or fetal death, results in malignancy

    Measured: during entire follow-up

  9. Stent fracture rate at 12 months

    Stent fracture rate at 12 months, determined by using the following classifications on X-ray:

    1. Class 0 : no strut factures
    2. Class I : single tine fracture
    3. Class II : multiple tine factures
    4. Class III : Stent fracture(s) with preserved alignment of the components
    5. Class IV : Stent fracture(s) with mal-alignment of the components
    6. Class V : Stent fracture(s) in a trans-axial spiral configuration

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Apr 2010 (estimated)
  2. Study startMay 2010
  3. Primary completionMar 2013
  4. Study completionMar 2014

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01108861
Sponsor's protocol ID
FMRP-100107
Acronym
RELINE
Status last verified
Sep 2014
First submitted
21 Apr 2010
Last updated
3 Sep 2014
Results posted
No
Data monitoring committee
No

Publications

  • Bosiers M, Deloose K, Callaert J, Verbist J, Hendriks J, Lauwers P, Schroe H, Lansink W, Scheinert D, Schmidt A, Zeller T, Beschorner U, Noory E, Torsello G, Austermann M, Peeters P. Superiority of stent-grafts for in-stent restenosis in the superficial femoral artery: twelve-month results from a multicenter randomized trial. J Endovasc Ther. 2015 Feb;22(1):1-10. doi: 10.1177/1526602814564385.

    PubMed 25775672

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing GORE VIABAHN® Endoprosthesis and Plain old balloon angioplasty in people with Peripheral Vascular Disease, run by Flanders Medical Research Program at 6 sites in 2 countries.

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 0 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 3 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Belgium, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (CFDU) and without target lesion revascularization (TLR) within 12 months. (time frame: 1 year). 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 NCT01108861, which also lists 1 linked publication.

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 3 Sep 2014.

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