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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2010 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen Identifier:
First received: February 26, 2010
Last updated: March 7, 2014
Last verified: April 2010
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.

Condition Intervention Phase
Peripheral Vascular Disease
Device: PTA
Device: PTA with PEB
Procedure: Percutaneous Transluminal Angioplasty (PTA)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • Percentage diameter stenosis [ Time Frame: 6 months ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 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 ]
  • Time to onset of any of MAPE [ Time Frame: 3-24 months ]
  • Binary restenosis rate [ Time Frame: 6 months ]
  • Percentage diameter stenosis in duplex ultrasound [ Time Frame: 6 and 24 months ]

Estimated Enrollment: 70
Study Start Date: March 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: conventional PTA
In stent restenosis is treated with PTA using a conventional balloon.
Device: PTA
PTA using a conventional balloon
Other Name: PACIFIC XTREME, Invatec
Procedure: Percutaneous Transluminal Angioplasty (PTA)
Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon
Experimental: PTA with PEB
In stent restenosis is treated with PTA using a paclitaxel eluting balloon.
Device: PTA with PEB
PTA using a paclitaxel eluting balloon
Other Name: IN.PACT PACIFIC, Invatec
Procedure: Percutaneous Transluminal Angioplasty (PTA)
Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01083394

1. Medizinische Klinik, Klinikum rechts der Isar
Muenchen, Germany
Deutsches Herzzentrum
Muenchen, Germany
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Ilka V. Ott, MD Klinikum rechts der Isar
  More Information

Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT01083394     History of Changes
Other Study ID Numbers: GE IDE No. B00210 
Study First Received: February 26, 2010
Last Updated: March 7, 2014

Keywords provided by Deutsches Herzzentrum Muenchen:

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Diseases
Arterial Occlusive Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action processed this record on January 19, 2017