Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery (ISAR-PEBIS)

German Heart Center Munich

Status and phase: Unknown; Phase 4

Conditions: Peripheral Vascular Disease

Treatments: Device: PTA; Procedure: Percutaneous Transluminal Angioplasty (PTA); Device: PTA with PEB

Study type: Interventional

Funder types: Other

Identifiers

NCT01083394

GE IDE No. B00210

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

conventional PTA

Active Comparator group

Description:

In stent restenosis is treated with PTA using a conventional balloon.

Treatment:

Procedure: Percutaneous Transluminal Angioplasty (PTA)

Device: PTA

PTA with PEB

Experimental group

Description:

In stent restenosis is treated with PTA using a paclitaxel eluting balloon.

Treatment:

Device: PTA with PEB

Procedure: Percutaneous Transluminal Angioplasty (PTA)