Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery

Phase 4

• Conditions: Peripheral Vascular Disease
• Interventions: Device: PTA; Device: PTA with PEB; Procedure: Percutaneous Transluminal Angioplasty (PTA)

• Registration Number: NCT01083394
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.

Detailed Description

The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Restenosis after PTA occurs in 40-60% within one year. A novel attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. There is no randomized comparison of these treatments in patients with in stent restenosis of the superficial femoral artery. Thus, the aim of this study was to compare the efficacy of PTA with conventional balloon or PEB for in stent restenosis in the SFA in terms of reduction of diameter stenosis at follow-up angiogram.

Study Timeline

• Study First Submitted: 2010-02-26
• Study Start: 2010-03
• Study First Submitted QC: 2010-03-08
• Study First Posted: 2010-03-09
• Status Verified: 2010-04
• Last Update Submitted: 2014-03-07
• Last Update Posted: 2014-03-10
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• Symptomatic ≥ 70% in-stent restenosis of the AFS, (Rutherford stage 2-6)
• Written, informed consent by the patient or her/his legally-authorized representative for participation in the study

Exclusion Criteria

• Acute ischemia and/or acute thrombosis of the SFA
• Untreated ipsilateral iliac artery stenosis >70%
• Not at least one vessel run-off
• Popliteal involvement with stenosis >70%
• Severe renal insufficiency (GFR <30 ml/min/m2)
• Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
• Pregnancy (present, suspected or planned) or positive pregnancy test.
• Previous enrollment in this trial.
• Patient's inability to fully cooperate with the study protocol.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional PTA	PTA	In stent restenosis is treated with PTA using a conventional balloon.
PTA with PEB	Percutaneous Transluminal Angioplasty (PTA)	In stent restenosis is treated with PTA using a paclitaxel eluting balloon.
PTA with PEB	PTA with PEB	In stent restenosis is treated with PTA using a paclitaxel eluting balloon.
conventional PTA	Percutaneous Transluminal Angioplasty (PTA)	In stent restenosis is treated with PTA using a conventional balloon.

Primary Outcome Measures

Name	Time	Method
Percentage diameter stenosis	6 months

Secondary Outcome Measures

Name	Time	Method
All-cause mortality	6 and 24 months
Percentage diameter stenosis in duplex ultrasound	6 and 24 months
Time to onset of any of MAPE	3-24 months
Binary restenosis rate	6 months
Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)	6 Months

Trial Locations

Locations (2)

1. Medizinische Klinik, Klinikum rechts der Isar; 🇩🇪 Muenchen, Germany

Deutsches Herzzentrum; 🇩🇪 Muenchen, Germany