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

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Vascular Disease
• Intervention / Treatment: Device: Admiral Xtreme; Device: In.Pact Admiral

• Study Type: Interventional
• Enrollment (Anticipated): 118
• Phase: Phase 4

Contacts and Locations

Study Locations

• Germany
  • Hamburg, Germany, 22527
    • Medical Care Center Prof. Mathey, Prof. Schofer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: In.Pact Admiral, Invatec

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recurrent restenosis within the stent at 12 month	Recurrent restenosis >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4	12 month
Clinically driven target lesion revascularization (TLR) at 6 and 12 month		6 and 12 month
Recurrent stenosis >= 70% within the stent at 6 and 12 month	Recurrent restenosis >= 70% measured as proximal peak velocity ratio PVR[prox] >= 3.4	6 and 12 month
Clinical and hemodynamic parameters	Walking distance, ABI, Rutherford category	at 1, 6 and 12 month
Primary angiographic success rate	Angiographic sucess: <50% residual stenosis	12 month
Major adverse vascular events (MAVE)		12 month
Death		12 month
Impact of "bail-out" stent-in-stent placement on 6-and 12-month end points		6 and 12 month

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): December 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: February 25, 2011
• First Submitted That Met QC Criteria: February 25, 2011
• First Posted (Estimate): February 28, 2011

Study Record Updates

• Last Update Posted (Estimate): February 6, 2015
• Last Update Submitted That Met QC Criteria: February 5, 2015
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: POBA; Superficial femoral artery; Standard balloon angioplasty; Angioplasty with paclitaxel-eluting balloon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: FAIR 3.0