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

NCT ID: NCT01083394

Last Updated: 2014-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2015-12-31

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.

Conditions

Peripheral Vascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

conventional PTA

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

Group Type: ACTIVE_COMPARATOR

PTA

Intervention Type: DEVICE

PTA using a conventional balloon

Percutaneous Transluminal Angioplasty (PTA)

Intervention Type: PROCEDURE

Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon

PTA with PEB

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

Group Type: EXPERIMENTAL

PTA with PEB

Intervention Type: DEVICE

PTA using a paclitaxel eluting balloon

Percutaneous Transluminal Angioplasty (PTA)

Intervention Type: PROCEDURE

Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon

Interventions

PTA

PTA using a conventional balloon

Intervention Type: DEVICE

PTA with PEB

PTA using a paclitaxel eluting balloon

Intervention Type: DEVICE

Percutaneous Transluminal Angioplasty (PTA)

Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon

Intervention Type: PROCEDURE

Other Intervention Names

PACIFIC XTREME, Invatec; IN.PACT PACIFIC, Invatec; PACIFIC XTREME or IN.PACT PACIFIC balloons

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adnan Kastrati, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Muenchen

Ilka V. Ott, MD

Role: PRINCIPAL_INVESTIGATOR

Klinikum rechts der Isar

Locations

1. Medizinische Klinik, Klinikum rechts der Isar

München, , Germany

Site Status: RECRUITING

Deutsches Herzzentrum

München, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Julinda Mehilli, MD

Role: CONTACT

mehilli@dhm.mhn.de

+49 89 12 18 ext. 4582

Ilka V. Ott, MD

Role: CONTACT

ott@dhm.de

+49 89 41 40 ext. 4360

Facility Contacts

Ilka V. Ott, MD

Role: primary

ott@dhm.mhn.de

+49 89 4140 ext. 4360

Massimiliano Fusaro, MD

Role: primary

fusaro@dhm.mhn.de

+49 89 1218 ext. 4566

Tarek Ibrahim, MD

Role: backup

ibrahim@dhm.mhn.de

+49 89 1218 ext. 4016

References

Ott I, Cassese S, Groha P, Steppich B, Voll F, Hadamitzky M, Ibrahim T, Kufner S, Dewitz K, Wittmann T, Kasel AM, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): A Randomized Trial. J Am Heart Assoc. 2017 Jul 25;6(7):e006321. doi: 10.1161/JAHA.117.006321.

Reference Type: DERIVED

PMID: 28743787 (View on PubMed)

Other Identifiers

GE IDE No. B00210

Identifier Type: -

Identifier Source: org_study_id