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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
ClinicalTrials.gov Identifier:
NCT01305070
First received: February 25, 2011
Last updated: April 24, 2013
Last verified: April 2013

February 25, 2011
April 24, 2013
January 2010
December 2012   (final data collection date for primary outcome measure)
Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA) [ Time Frame: 6 month ] [ Designated as safety issue: Yes ]
Binary restenosis rate by Duplex-ultrasound >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4
Same as current
Complete list of historical versions of study NCT01305070 on ClinicalTrials.gov Archive Site
  • Recurrent restenosis within the stent at 12 month [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
    Recurrent restenosis >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4
  • Clinically driven target lesion revascularization (TLR) at 6 and 12 month [ Time Frame: 6 and 12 month ] [ Designated as safety issue: Yes ]
  • Recurrent stenosis >= 70% within the stent at 6 and 12 month [ Time Frame: 6 and 12 month ] [ Designated as safety issue: Yes ]
    Recurrent restenosis >= 70% measured as proximal peak velocity ratio PVR[prox] >= 3.4
  • Clinical and hemodynamic parameters [ Time Frame: at 1, 6 and 12 month ] [ Designated as safety issue: No ]
    Walking distance, ABI, Rutherford category
  • Primary angiographic success rate [ Time Frame: 12 month ] [ Designated as safety issue: No ]
    Angiographic sucess: <50% residual stenosis
  • Major adverse vascular events (MAVE) [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: 12 month ] [ Designated as safety issue: Yes ]
  • Impact of "bail-out" stent-in-stent placement on 6-and 12-month end points [ Time Frame: 6 and 12 month ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Standard Balloon Angioplasty Versus Angioplasty With a Paclitaxel-eluting Balloon for Femoral Artery In-stent Restenosis
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).

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Vascular Disease
  • Device: Admiral Xtreme
    For balloon angioplasty of in-stent restenosis in the superficial femoral artery
    Other Name: Admiral Xtreme, Invatec
  • Device: In.Pact Admiral
    For balloon angioplasty of in-stent restenosis in the superficial femoral artery
    Other Name: In.Pact Admiral, Invatec
  • Active Comparator: Standart balloon angioplasty
    Admiral Xtreme, Invatec
    Intervention: Device: Admiral Xtreme
  • Active Comparator: Paclitaxel-eluting balloon arm
    In.Pact Admiral, Invatec
    Intervention: Device: In.Pact Admiral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
118
June 2013
December 2012   (final data collection date for primary outcome measure)

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:

General:

  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.

    Angiographic:

  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.
Both
21 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01305070
FAIR 3.0
No
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Not Provided
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
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP