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

• ClinicalTrials.gov Identifier: NCT01305070
• Recruitment Status: Completed
• First Posted: February 28, 2011
• Last Update Posted: February 6, 2015
• Sponsor: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
• Information provided by (Responsible Party): Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

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
• Actual Primary Completion Date: December 2012
• Actual Study Completion Date: June 2013

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

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Krankenberg H, Tübler T, Ingwersen M, Schlüter 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.

• Responsible Party: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
• ClinicalTrials.gov Identifier: NCT01305070
• Other Study ID Numbers: FAIR 3.0
• First Posted: February 28, 2011
• Last Update Posted: February 6, 2015
• Last Verified: April 2013

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