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

Primary Purpose

Peripheral Vascular Disease

Status

Completed

Phase

Phase 4

Locations

Germany

Study Type

Interventional

Intervention

Admiral Xtreme

In.Pact Admiral

About this trial

This is an interventional treatment trial for Peripheral Vascular Disease focused on measuring Standard balloon angioplasty, POBA, Angioplasty with paclitaxel-eluting balloon, Superficial femoral artery

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.
Angiographic Inclusion Criteria:
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.

Exclusion Criteria:

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.
Angiographic:
Target lesion extends into the popliteal artery.
Symptomatic untreated inflow lesion > 50% in ipsilateral iliac arteries. Pretreatment of iliac stenoses is possible.
SFA lesions > 50% stenosis proximal and/or distal to the target lesion that require treatment.
Target lesion extends beyond the stent margins.

Sites / Locations

Medical Care Center Prof. Mathey, Prof. Schofer

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Standart balloon angioplasty

Paclitaxel-eluting balloon arm

Arm Description

Admiral Xtreme, Invatec

In.Pact Admiral, Invatec

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Recurrent restenosis within the stent at 12 month

Recurrent restenosis >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4

Clinically driven target lesion revascularization (TLR) at 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

Clinical and hemodynamic parameters

Walking distance, ABI, Rutherford category

Primary angiographic success rate

Angiographic sucess: <50% residual stenosis

Major adverse vascular events (MAVE)

Death

Impact of "bail-out" stent-in-stent placement on 6-and 12-month end points

Full Information

NCT ID

NCT01305070

First Posted

February 25, 2011

Last Updated

February 5, 2015

Sponsor

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

1. Study Identification

Unique Protocol Identification Number

NCT01305070

Brief Title

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

Acronym

FAIR

Official Title

Femoral Artery In-Stent Restenosis (FAIR) Trial

Study Type

Interventional

2. Study Status

Record Verification Date

April 2013

Overall Recruitment Status

Completed

Study Start Date

January 2010 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

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

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Vascular Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

118 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standart balloon angioplasty

Arm Type

Active Comparator

Arm Description

Admiral Xtreme, Invatec

Arm Title

Paclitaxel-eluting balloon arm

Arm Type

Active Comparator

Arm Description

In.Pact Admiral, Invatec

Intervention Type

Device

Intervention Name(s)

Admiral Xtreme

Other Intervention Name(s)

Admiral Xtreme, Invatec

Intervention Description

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

Intervention Type

Device

Intervention Name(s)

In.Pact Admiral

Other Intervention Name(s)

In.Pact Admiral, Invatec

Intervention Description

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

Primary Outcome Measure Information:

Title

Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA)

Description

Binary restenosis rate by Duplex-ultrasound >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4

Time Frame

6 month

Secondary Outcome Measure Information:

Title

Recurrent restenosis within the stent at 12 month

Description

Recurrent restenosis >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4

Time Frame

12 month

Title

Clinically driven target lesion revascularization (TLR) at 6 and 12 month

Time Frame

6 and 12 month

Title

Recurrent stenosis >= 70% within the stent at 6 and 12 month

Description

Recurrent restenosis >= 70% measured as proximal peak velocity ratio PVR[prox] >= 3.4

Time Frame

6 and 12 month

Title

Clinical and hemodynamic parameters

Description

Walking distance, ABI, Rutherford category

Time Frame

at 1, 6 and 12 month

Title

Primary angiographic success rate

Description

Angiographic sucess: <50% residual stenosis

Time Frame

12 month

Title

Major adverse vascular events (MAVE)

Time Frame

12 month

Title

Death

Time Frame

12 month

Title

Impact of "bail-out" stent-in-stent placement on 6-and 12-month end points

Time Frame

6 and 12 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Angiographic Inclusion Criteria: 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. Exclusion Criteria: 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. Angiographic: Target lesion extends into the popliteal artery. Symptomatic untreated inflow lesion > 50% in ipsilateral iliac arteries. Pretreatment of iliac stenoses is possible. SFA lesions > 50% stenosis proximal and/or distal to the target lesion that require treatment. Target lesion extends beyond the stent margins.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hans Krankenberg, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Thilo Tübler, MD

Organizational Affiliation

Medical Care Center Prof. Mathey, Prof. Schofer

Official's Role

Study Chair

Facility Information:

Facility Name

Medical Care Center Prof. Mathey, Prof. Schofer

City

Hamburg

ZIP/Postal Code

22527

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

26446728

Citation

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.

Results Reference

derived

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

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