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

March 7, 2014 updated by: Deutsches Herzzentrum Muenchen

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)

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenchen, Germany
        • Recruiting
        • 1. Medizinische Klinik, Klinikum rechts der Isar
        • Contact:
          • Ilka V. Ott, MD
          • Phone Number: 4360 +49 89 4140
          • Email: ott@dhm.mhn.de
        • Principal Investigator:
          • Ilka V. Ott, MD
      • Muenchen, Germany
        • Recruiting
        • Deutsches Herzzentrum
        • Principal Investigator:
          • Massimiliano Fusaro, MD
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: conventional PTA
In stent restenosis is treated with PTA using a conventional balloon.
Device: PTA
PTA using a conventional balloon
Other Names:
  • PACIFIC XTREME, Invatec
Procedure: Percutaneous Transluminal Angioplasty (PTA)
Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon
Other Names:
  • PACIFIC XTREME or IN.PACT PACIFIC balloons
Experimental: PTA with PEB
In stent restenosis is treated with PTA using a paclitaxel eluting balloon.
Procedure: Percutaneous Transluminal Angioplasty (PTA)
Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon
Other Names:
  • PACIFIC XTREME or IN.PACT PACIFIC balloons
Device: PTA with PEB
PTA using a paclitaxel eluting balloon
Other Names:
  • IN.PACT PACIFIC, Invatec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage diameter stenosis
Time Frame: 6 months
6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deutsches Herzzentrum Muenchen

Investigators

  • Study Chair: Adnan Kastrati, MD, Deutsches Herzzentrum Muenchen
  • Principal Investigator: Ilka V. Ott, MD, Klinikum Rechts der Isar

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

February 26, 2010

First Submitted That Met QC Criteria

March 8, 2010

First Posted (Estimate)

March 9, 2010

Study Record Updates

Last Update Posted (Estimate)

March 10, 2014

Last Update Submitted That Met QC Criteria

March 7, 2014

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. B00210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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