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
  Purpose

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 Intervention Phase
Peripheral Vascular Disease
Device: Admiral Xtreme
Device: In.Pact Admiral
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Femoral Artery In-Stent Restenosis (FAIR) Trial

Resource links provided by NLM:


Further study details as provided by Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 118
Study Start Date: January 2010
Estimated Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305070

Locations
Germany
Medical Care Center Prof. Mathey, Prof. Schofer
Hamburg, Germany, 22527
Sponsors and Collaborators
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Investigators
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

No publications provided

Responsible Party: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
ClinicalTrials.gov Identifier: NCT01305070     History of Changes
Other Study ID Numbers: FAIR 3.0
Study First Received: February 25, 2011
Last Updated: April 24, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 16, 2014