Clinical trial NCT01305070: Standard Balloon Angioplasty Versus Angioplasty With a Paclitaxel-eluting Balloon for Femoral Artery In-stent Restenosis
Official title: Femoral Artery In-Stent Restenosis (FAIR) Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Peripheral Vascular Disease
Keywords: Standard balloon angioplasty
POBA
Angioplasty with paclitaxel-eluting balloon
Superficial femoral artery
Lead sponsor: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
Sponsor class: OTHER
First posted: 2011-02-28
Enrollment: 118
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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.

Primary outcomes:
measure: Duplex-ultrasound determined recurrent restenosis in the superficial femoral artery (SFA)
timeFrame: 6 month
Secondary outcomes:
measure: Recurrent restenosis within the stent at 12 month
timeFrame: 12 month
measure: Clinically driven target lesion revascularization (TLR) at 6 and 12 month
timeFrame: 6 and 12 month
measure: Recurrent stenosis >= 70% within the stent at 6 and 12 month
timeFrame: 6 and 12 month
measure: Clinical and hemodynamic parameters
timeFrame: at 1, 6 and 12 month
measure: Primary angiographic success rate
timeFrame: 12 month
measure: Major adverse vascular events (MAVE)
timeFrame: 12 month
measure: Death
timeFrame: 12 month
measure: Impact of "bail-out" stent-in-stent placement on 6-and 12-month end points
timeFrame: 6 and 12 month
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Medical Care Center Prof. Mathey, Prof. Schofer
Study officials:
affiliation: Medical Care Center Prof. Mathey, Prof. Schof Ltd.
name: Hans Krankenberg, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Care Center Prof. Mathey, Prof. Schofer
name: Thilo Tübler, MD
role: STUDY_CHAIR
References:
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.