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

Peripheral Vascular Disease Clinical Trial

— ISAR-PEBIS  

Official title:

Randomized Trial of Paclitaxel Eluting Balloon or Conventional Balloon for Treatment of In-Stent Restenosis of the Superficial Femoral Artery in Patients With Symptomatic Peripheral Artery Disease (ISAR-PEBIS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01083394
• Other study ID #: GE IDE No. B00210
• Status: Recruiting
• Phase: Phase 4
• First received: February 26, 2010
• Last updated: March 7, 2014
• Start date: March 2010
• Est. completion date: December 2015

Study information

• Verified date: April 2010
• Source: Deutsches Herzzentrum Muenchen
• Contact: Julinda Mehilli, MD
• Phone: +49 89 12 18
• Email: mehilli[@]dhm.mhn.de
• Is FDA regulated: No
• Health authority: Germany: German Institute of Medical Documentation and Information
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Device:
• PTA
PTA using a conventional balloon
• PTA with PEB
PTA using a paclitaxel eluting balloon

Procedure:
• Percutaneous Transluminal Angioplasty (PTA)
Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon

Locations

Country	Name	City	State
Germany	1. Medizinische Klinik, Klinikum rechts der Isar	Muenchen
Germany	Deutsches Herzzentrum	Muenchen

Sponsors (1)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage diameter stenosis		6 months	No
Secondary	All-cause mortality		6 and 24 months	Yes
Secondary	Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)		6 Months	Yes
Secondary	Time to onset of any of MAPE		3-24 months	Yes
Secondary	Binary restenosis rate		6 months	No
Secondary	Percentage diameter stenosis in duplex ultrasound		6 and 24 months	No