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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2010 by Deutsches Herzzentrum Muenchen
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT00986752
First received: September 29, 2009
Last updated: March 6, 2014
Last verified: January 2010
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Diseases
Device: Stenting (Smart Stent)
Device: Stenting after PEB (Smart Stent, Invatec)
Procedure: Atherectomy (SilverHawk device)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Trial of Stenting After Dilation With or Without Paclitaxel Eluting Balloon or Atherectomy in Patients With Symptomatic Peripheral Artery Disease

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 ]
  • Change from baseline in functional status and health related quality of life (Walking Impairment Questionaire) [ Time Frame: 3 and 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: July 2009
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Smart Stent, Cordis, Johnson & Johnson
Device: Stenting after PEB (Smart Stent, Invatec)
Stenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB).
Other Names:
  • Invatec
  • Smart Stent, Cordis, Johnson & Johnson
Experimental: Atherectomy
The third randomization arm is Atherectomy.
Procedure: Atherectomy (SilverHawk device)
Atherectomy
Other Name: SilverHawk device (EV3 Inc)

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00986752

Contacts
Contact: Klaus Tiroch, MD +49-89-1218 ext 1538 tiroch@dhm.mhn.de
Contact: Tarek Ibrahim, MD +49 89-1218 ext 4018 ibrahim@dhm.mhn.de

Locations
Germany
I. Medizinische Klinik, Klinikum rechts der Isar Recruiting
Muenchen, Germany, 81675
Contact: Ilka Ott, MD    +49-89-4140 ext 4360    ott@dhm.mhn.de   
Principal Investigator: Ilka Ott, MD         
Deutsches Herzzentrum Recruiting
Muenchen, Germany, 80636
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 München
Principal Investigator: Ilka Ott, MD Klinikum rechts der Isar
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00986752     History of Changes
Other Study ID Numbers: GE IDE No. B00101
Study First Received: September 29, 2009
Last Updated: March 6, 2014
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Deutsches Herzzentrum Muenchen:
stent
atherectomy
paclitaxel-eluting balloon

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

ClinicalTrials.gov processed this record on September 29, 2014