Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease (ISAR-STATH)

March 6, 2014 updated by: Deutsches Herzzentrum Muenchen

Randomized Trial of Stenting After Dilation With or Without Paclitaxel Eluting Balloon or Atherectomy in Patients With Symptomatic Peripheral Artery Disease

The purpose of the study is to evaluate the efficacy of stenting after dilation with or without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral artery disease.

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. Despite the initial technical success rate of more than 95% the late clinical failure remains an important concern.

Restenosis after PTA occurs in 40-60% within one year. Percutaneous removal of the obstructive material through atherectomy may reduce restenosis rate. So far, data in support of excisional atherectomy derive from registries. Another 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 this three different interventional strategies. Thus the aim of this study is to evaluate the efficacy of these strategies in terms or reduction of diameter stenosis at follow-up angiogram.

Study Type

Interventional

Enrollment (Anticipated)

150

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 Contact

Study Contact Backup

Study Locations

  • Germany
      • Muenchen, Germany, 80636
        • Recruiting
        • Deutsches Herzzentrum
        • Contact:
        • Contact:
        • Principal Investigator:
          • Massimiliano Fusaro, MD
      • Muenchen, Germany, 81675
        • Recruiting
        • I. Medizinische Klinik, Klinikum rechts der Isar
        • 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% stenosis of the SFA (Rutherford stage 2-6)
  • Written informed consent

Exclusion Criteria:

  • Acute ischemia and/or acute thrombosis of the SFA
  • Untreated ipsilateral iliac artery stenosis >70%
  • Previous stenting of the SFA
  • Popliteal stenosis >70%
  • Severe renal insufficiency

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: Stenting
Due to randomization one nitinol stent will be implanted after dilation with a conventional balloon.
Device: Stenting (Smart Stent)
Nitinol stent
Other Names:
  • Smart Stent, Cordis, Johnson & Johnson
Experimental: Stenting after PEB
Due to randomization one nitinol stent will be implanted after dilation with a Paclitaxel eluting balloon.
Device: Stenting (Smart Stent)
Nitinol stent
Other Names:
  • Smart Stent, Cordis, Johnson & Johnson
Device: Stenting after PEB (Smart Stent, Invatec)
Stenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB).
Other Names:
  • Smart Stent, Cordis, Johnson & Johnson
  • Invatec
Experimental: Atherectomy
The third randomization arm is Atherectomy.
Procedure: Atherectomy (SilverHawk device)
Atherectomy
Other Names:
  • SilverHawk device (EV3 Inc)

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
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
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
Change from baseline in functional status and health related quality of life (Walking Impairment Questionaire)
Time Frame: 3 and 6 months
3 and 6 months

Collaborators and Investigators

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

Sponsor

Deutsches Herzzentrum Muenchen

Investigators

  • Principal Investigator: Ilka 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

July 1, 2009

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

September 29, 2009

First Submitted That Met QC Criteria

September 29, 2009

First Posted (Estimate)

September 30, 2009

Study Record Updates

Last Update Posted (Estimate)

March 7, 2014

Last Update Submitted That Met QC Criteria

March 6, 2014

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GE IDE No. B00101

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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