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

Sponsor:	Deutsches Herzzentrum Muenchen
Information provided by:	Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:	NCT01083394

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 IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Control: Active Control 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:

MedlinePlus related topics: Angioplasty Peripheral Arterial Disease Vascular Diseases

Drug Information available for: Paclitaxel

U.S. FDA Resources

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:	July 2013
Estimated Primary Completion Date:	July 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
conventional PTA: Active Comparator In stent restenosis is treated with PTA using a conventional balloon.	Device: PTA PTA using a conventional balloon Procedure: Percutaneous Transluminal Angioplasty (PTA) Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon
PTA with PEB: Experimental In stent restenosis is treated with PTA using a paclitaxel eluting balloon.	Device: PTA with PEB PTA using a paclitaxel eluting balloon 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.

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

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 ( Prof. Dr. A. Schoemig )
ClinicalTrials.gov Identifier:	NCT01083394 History of Changes
Other Study ID Numbers:	GE IDE No. B00210
Study First Received:	February 26, 2010
Last Updated:	April 7, 2010
Health Authority:	Germany: German Institute of Medical Documentation and Information

Keywords provided by Deutsches Herzzentrum Muenchen:

PTA
paclitaxel
restenosis

Additional relevant MeSH terms:

Vascular Diseases
Peripheral Vascular Diseases
Cardiovascular Diseases
Paclitaxel
Tubulin Modulators
Antimitotic Agents

Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 01, 2010