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

Peripheral Vascular Disease Clinical Trial

— FAIR  

Official title:

Femoral Artery In-Stent Restenosis (FAIR) Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01305070
• Other study ID #: FAIR 3.0
• Status: Completed
• Phase: Phase 4
• First received: February 25, 2011
• Last updated: February 5, 2015
• Start date: January 2010
• Est. completion date: June 2013

Study information

• Verified date: April 2013
• Source: Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: June 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• Admiral Xtreme
For balloon angioplasty of in-stent restenosis in the superficial femoral artery
• In.Pact Admiral
For balloon angioplasty of in-stent restenosis in the superficial femoral artery

Locations

Country	Name	City	State
Germany	Medical Care Center Prof. Mathey, Prof. Schofer	Hamburg

Sponsors (1)

Lead Sponsor	Collaborator
Medical Care Center Prof. Mathey, Prof. Schofer, Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	Recurrent restenosis within the stent at 12 month	Recurrent restenosis >= 50% measured as proximal peak velocity ratio PVR[prox] >= 2.4	12 month	Yes
Secondary	Clinically driven target lesion revascularization (TLR) at 6 and 12 month		6 and 12 month	Yes
Secondary	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	Yes
Secondary	Clinical and hemodynamic parameters	Walking distance, ABI, Rutherford category	at 1, 6 and 12 month	No
Secondary	Primary angiographic success rate	Angiographic sucess: <50% residual stenosis	12 month	No
Secondary	Major adverse vascular events (MAVE)		12 month	Yes
Secondary	Death		12 month	Yes
Secondary	Impact of "bail-out" stent-in-stent placement on 6-and 12-month end points		6 and 12 month	Yes