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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01305070
Recruitment Status : Completed
First Posted : February 28, 2011
Last Update Posted : February 6, 2015
Information provided by (Responsible Party):

Study Description
Brief 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).

Condition or disease Intervention/treatment Phase
Peripheral Vascular Disease Device: Admiral Xtreme Device: In.Pact Admiral Phase 4

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Femoral Artery In-Stent Restenosis (FAIR) Trial
Study Start Date : January 2010
Primary Completion Date : December 2012
Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Standart balloon angioplasty
Admiral Xtreme, Invatec
Device: Admiral Xtreme
For balloon angioplasty of in-stent restenosis in the superficial femoral artery
Other Name: Admiral Xtreme, Invatec
Active Comparator: Paclitaxel-eluting balloon arm
In.Pact Admiral, Invatec
Device: In.Pact Admiral
For balloon angioplasty of in-stent restenosis in the superficial femoral artery
Other Name: In.Pact Admiral, Invatec

Outcome Measures

Primary Outcome Measures :
  1. Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA) [ Time Frame: 6 month ]
    Binary restenosis rate by Duplex-ultrasound >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4

Secondary Outcome Measures :
  1. Recurrent restenosis within the stent at 12 month [ Time Frame: 12 month ]
    Recurrent restenosis >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4

  2. Clinically driven target lesion revascularization (TLR) at 6 and 12 month [ Time Frame: 6 and 12 month ]
  3. Recurrent stenosis >= 70% within the stent at 6 and 12 month [ Time Frame: 6 and 12 month ]
    Recurrent restenosis >= 70% measured as proximal peak velocity ratio PVR[prox] >= 3.4

  4. Clinical and hemodynamic parameters [ Time Frame: at 1, 6 and 12 month ]
    Walking distance, ABI, Rutherford category

  5. Primary angiographic success rate [ Time Frame: 12 month ]
    Angiographic sucess: <50% residual stenosis

  6. Major adverse vascular events (MAVE) [ Time Frame: 12 month ]
  7. Death [ Time Frame: 12 month ]
  8. Impact of "bail-out" stent-in-stent placement on 6-and 12-month end points [ Time Frame: 6 and 12 month ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age > 21 years old.
  2. Patient must sign informed consent form.
  3. Patient must agree to participate in the study and comply with follow-up requirements.
  4. Clinically, all patients must be in Rutherford category 2 to 4.

    Angiographic Inclusion Criteria:

  5. 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!
  6. The length of the in-stent lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler).
  7. The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound.
  8. 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).
  9. Patency (< 50% stenosis) of popliteal artery and at least 1 infragenicular artery.

Exclusion Criteria:


  1. Patient is currently participating in another clinical trial.
  2. Pregnancy or pregnancy planned during study duration.
  3. Life expectancy less than 1 year.
  4. Co-morbidities preventing study participation.
  5. Severe coagulation disorders.
  6. Current treatment with anticoagulants other than aspirin, ticlopidine, clopidogrel or prasugrel.
  7. Active gastric ulcer or gastrointestinal bleeding.
  8. Thrombotic occlusion of the target vessel within previous 4 weeks.
  9. Treatment of target lesion with laser or atherectomy devices.
  10. Dialysis dependency.
  11. Manifest hyperthyreosis.
  12. Known allergy against contrast agent that cannot be adequately controlled by usual premedication.
  13. Known heparin intolerance.
  14. Known paclitaxel intolerance.


  15. Target lesion extends into the popliteal artery.
  16. Symptomatic untreated inflow lesion > 50% in ipsilateral iliac arteries. Pretreatment of iliac stenoses is possible.
  17. SFA lesions > 50% stenosis proximal and/or distal to the target lesion that require treatment.
  18. Target lesion extends beyond the stent margins.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01305070

Medical Care Center Prof. Mathey, Prof. Schofer
Hamburg, Germany, 22527
Sponsors and Collaborators
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Principal Investigator: Hans Krankenberg, MD Medical Care Center Prof. Mathey, Prof. Schof Ltd.
Study Chair: Thilo Tübler, MD Medical Care Center Prof. Mathey, Prof. Schofer
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
ClinicalTrials.gov Identifier: NCT01305070     History of Changes
Other Study ID Numbers: FAIR 3.0
First Posted: February 28, 2011    Key Record Dates
Last Update Posted: February 6, 2015
Last Verified: April 2013

Keywords provided by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.:
Standard balloon angioplasty
Angioplasty with paclitaxel-eluting balloon
Superficial femoral artery

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action