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

NCT01305070 | Completed Phase 4

• 1 other identifier: FAIR 3.0
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Vascular Disease

Keywords

Standard balloon angioplasty; POBA; Angioplasty with paclitaxel-eluting balloon; Superficial femoral artery

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Recurrent restenosis within the stent at 12 month

  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

  6 and 12 month

• Clinical and hemodynamic parameters

  at 1, 6 and 12 month

• Primary angiographic success rate

  12 month

Study Arms (2)

Standart balloon angioplasty

ACTIVE COMPARATOR

Admiral Xtreme, Invatec

Device: Admiral Xtreme

Paclitaxel-eluting balloon arm

ACTIVE COMPARATOR

In.Pact Admiral, Invatec

Device: In.Pact Admiral

Interventions

Admiral Xtreme DEVICE

For balloon angioplasty of in-stent restenosis in the superficial femoral artery

Also known as: Admiral Xtreme, Invatec

Standart balloon angioplasty

In.Pact Admiral DEVICE

For balloon angioplasty of in-stent restenosis in the superficial femoral artery

Also known as: In.Pact Admiral, Invatec

Paclitaxel-eluting balloon arm

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 21 years old.
• Patient must sign informed consent form.
• Patient must agree to participate in the study and comply with follow-up requirements.
• Clinically, all patients must be in Rutherford category 2 to 4.
• 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!
• The length of the in-stent lesion should be at least 1 cm and maximally 20 cm (measurement by radiopaque ruler).
• The degree of target lesion stenosis must be determined by pre-interventional duplex ultrasound.
• 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).
• Patency (\< 50% stenosis) of popliteal artery and at least 1 infragenicular artery.

You may not qualify if:

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

Sponsors & Collaborators

• Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.: lead

Study Sites (1)

Medical Care Center Prof. Mathey, Prof. Schofer

Hamburg, Hamburg, 22527, Germany

Location

Related Publications (1)

• 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.

  PMID: 26446728 DERIVED

MeSH Terms

Conditions

Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Hans Krankenberg, MD

  Medical Care Center Prof. Mathey, Prof. Schof Ltd.

  PRINCIPAL INVESTIGATOR

• Thilo Tübler, MD

  Medical Care Center Prof. Mathey, Prof. Schofer

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2011
• First Posted: February 28, 2011
• Study Start: January 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: February 6, 2015

Record last verified: 2013-04

Locations

DE (1)