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Peripheral Vascular DiseasePhase 4FAIRNCT01305070

Standard Balloon Angioplasty Versus Angioplasty With a Paclitaxel-eluting Balloon for Femoral Artery In-stent Restenosis

A Phase 4 study testing Admiral Xtreme and In.Pact Admiral in people with Peripheral Vascular Disease, run by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd. at 1 site in Germany.

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

Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral, Invatec). Read more about this study

Who is it for?
Ages 21 years and older
Conditions the study is for
Peripheral Vascular Disease
What is being tested?
Admiral Xtreme and In.Pact Admiral
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
118 participants
Where
1 siteGermany
Study dates
Jan 2010to Jun 2013
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 21 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 21 years old.
  • Patient must sign informed consent form.
  • Patient must agree to participate in the study and comply with follow-up requirements.
  • Clinically, all patients must be in Rutherford category 2 to 4.
  • Angiographic Inclusion Criteria:
  • Planned angioplasty of in-stent restenoses (degree of stenosis 70-100%) within the SFA. The target lesion must not extend beyond the stent margins. In cases of two or more stenotic regions within the stented segment, these are considered separate lesions if there is a nonstenotic or only mildly stenotic (< 30%) segment of at least 2 cm in length between them. Otherwise, they are considered a single lesion. In case of separate lesions, only the proximal lesion will be taken as the target lesion!
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  • The length of the in-stent lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler).
  • The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound.
  • The target lesion region starts at the origin of the SFA and ends distally at the femoropopliteal crossover (crossing by SFA of medial rim of femur in the PA projection).
  • Patency (< 50% stenosis) of popliteal artery and at least 1 infragenicular artery.

Who cannot join

  • General:
  • Patient is currently participating in another clinical trial.
  • Pregnancy or pregnancy planned during study duration.
  • Life expectancy less than 1 year.
  • Co-morbidities preventing study participation.
  • Severe coagulation disorders.
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  • Current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel.
  • Active gastric ulcer or gastrointestinal bleeding.
  • Thrombotic occlusion of the target vessel within previous 4 weeks.
  • Treatment of target lesion with laser or atherectomy devices.
  • Dialysis dependency.
  • Manifest hyperthyreosis.
  • Known allergy against contrast agent that cannot be adequately controlled by usual premedication.
  • Known heparin intolerance.
  • Known paclitaxel intolerance.
  • Angiographic:
  • Target lesion extends into the popliteal artery.
  • Symptomatic untreated inflow lesion > 50% in ipsilateral iliac arteries. Pretreatment of iliac stenoses is possible.
  • SFA lesions > 50% stenosis proximal and/or distal to the target lesion that require treatment.
  • Target lesion extends beyond the stent margins.

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Medical Care Center Prof. Mathey, Prof. Schofer

    Hamburg, Free and Hanseatic City of Hamburg, 22527

Other trials in Germany

About this study

Official title: Femoral Artery In-Stent Restenosis (FAIR) Trial

Comparison of recurrent-restenosis rates 6 months after angioplasty of in-stent restenoses or in-stent reocclusions in the superficial femoral artery (SFA) using either a standard balloon (Admiral Xtreme, Invatec) or a paclitaxel-eluting balloon (In.Pact™ Admiral, Invatec).

Being tested
Admiral Xtreme, In.Pact Admiral
Keywords
Standard balloon angioplasty, POBA, Angioplasty with paclitaxel-eluting balloon, Superficial femoral artery
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.

  • Admiral XtremeDevice

    Also called Admiral Xtreme, Invatec

    For balloon angioplasty of in-stent restenosis in the superficial femoral artery

  • In.Pact AdmiralDevice

    Also called In.Pact Admiral, Invatec

    For balloon angioplasty of in-stent restenosis in the superficial femoral artery

Study groups in NCT01305070
Study groupRoleWhat they receive
Standart balloon angioplastyActive comparatorAdmiral Xtreme, Invatec
Receives: Device: Admiral Xtreme
Paclitaxel-eluting balloon armActive comparatorIn.Pact Admiral, Invatec
Receives: Device: In.Pact Admiral

What is being measured

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

  1. Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA)

    Binary restenosis rate by Duplex-ultrasound >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4

    Measured: 6 month

Secondary outcomes (8)

  1. Recurrent restenosis within the stent at 12 month

    Recurrent restenosis >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4

    Measured: 12 month

  2. Clinically driven target lesion revascularization (TLR) at 6 and 12 month

    Measured: 6 and 12 month

  3. Recurrent stenosis >= 70% within the stent at 6 and 12 month

    Recurrent restenosis >= 70% measured as proximal peak velocity ratio PVR[prox] >= 3.4

    Measured: 6 and 12 month

  4. Clinical and hemodynamic parameters

    Walking distance, ABI, Rutherford category

    Measured: at 1, 6 and 12 month

  5. Primary angiographic success rate

    Angiographic sucess: <50% residual stenosis

    Measured: 12 month

  6. Major adverse vascular events (MAVE)

    Measured: 12 month

  7. Death

    Measured: 12 month

  8. Impact of "bail-out" stent-in-stent placement on 6-and 12-month end points

    Measured: 6 and 12 month

Timeline

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

  1. First posted28 Feb 2011 (estimated)
  2. Study startJan 2010
  3. Primary completionDec 2012
  4. Study completionJun 2013

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
None (open label)
Enrolment
118 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01305070
Sponsor's protocol ID
FAIR 3.0
Acronym
FAIR
Status last verified
Apr 2013
First submitted
25 Feb 2011
Last updated
6 Feb 2015
Results posted
No
Data monitoring committee
No

Publications

  • Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.

    PubMed 42573020

  • Krankenberg H, Tubler T, Ingwersen M, Schluter M, Scheinert D, Blessing E, Sixt S, Kieback A, Beschorner U, Zeller T. Drug-Coated Balloon Versus Standard Balloon for Superficial Femoral Artery In-Stent Restenosis: The Randomized Femoral Artery In-Stent Restenosis (FAIR) Trial. Circulation. 2015 Dec 8;132(23):2230-6. doi: 10.1161/CIRCULATIONAHA.115.017364. Epub 2015 Oct 7.

    PubMed 26446728

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Admiral Xtreme and In.Pact Admiral in people with Peripheral Vascular Disease, run by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd. at 1 site in Germany.

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 10 inclusion and 20 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 6 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in 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?

Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA) (time frame: 6 month). 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 NCT01305070, 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 6 Feb 2015.

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