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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2010 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01083394
First received: February 26, 2010
Last updated: March 7, 2014
Last verified: April 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: 6 and 24 months ] [ Designated as safety issue: Yes ]
  • Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Time to onset of any of MAPE [ Time Frame: 3-24 months ] [ Designated as safety issue: Yes ]
  • Binary restenosis rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Percentage diameter stenosis in duplex ultrasound [ Time Frame: 6 and 24 months ] [ Designated as safety issue: No ]

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
Other Name: PACIFIC XTREME or IN.PACT PACIFIC balloons
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
Other Name: PACIFIC XTREME or IN.PACT PACIFIC balloons

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01083394

Contacts
Contact: Julinda Mehilli, MD +49 89 12 18 ext 4582 mehilli@dhm.mhn.de
Contact: Ilka V. Ott, MD +49 89 41 40 ext 4360 ott@dhm.de

Locations
Germany
1. Medizinische Klinik, Klinikum rechts der Isar Recruiting
Muenchen, Germany
Contact: Ilka V. Ott, MD    +49 89 4140 ext 4360    ott@dhm.mhn.de   
Principal Investigator: Ilka V. Ott, MD         
Deutsches Herzzentrum Recruiting
Muenchen, Germany
Contact: Massimiliano Fusaro, MD    +49 89 1218 ext 4566    fusaro@dhm.mhn.de   
Contact: Tarek Ibrahim, MD    +49 89 1218 ext 4016    ibrahim@dhm.mhn.de   
Principal Investigator: Massimiliano Fusaro, MD         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Muenchen
Principal Investigator: Ilka V. Ott, MD Klinikum rechts der Isar
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01083394     History of Changes
Other Study ID Numbers: GE IDE No. B00210
Study First Received: February 26, 2010
Last Updated: March 7, 2014
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Deutsches Herzzentrum Muenchen:
PTA
paclitaxel
restenosis

Additional relevant MeSH terms:
Peripheral Arterial Disease
Peripheral Vascular Diseases
Vascular Diseases
Arterial Occlusive Diseases
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 29, 2014