We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00986752
Recruitment Status : Unknown
Verified January 2010 by Deutsches Herzzentrum Muenchen.
Recruitment status was:  Recruiting
First Posted : September 30, 2009
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

Brief Summary:
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 or disease Intervention/treatment Phase
Peripheral Vascular Diseases Device: Stenting (Smart Stent) Device: Stenting after PEB (Smart Stent, Invatec) Procedure: Atherectomy (SilverHawk device) Phase 4

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : July 2009
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel
U.S. FDA Resources

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 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)



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

Secondary Outcome Measures :
  1. All-cause mortality [ Time Frame: 6 and 24 months ]
  2. Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery) [ Time Frame: 6 months ]
  3. Time to onset of any of MAPE. [ Time Frame: 3-24 months ]
  4. Binary restenosis rate [ Time Frame: 6 months ]
  5. Percentage diameter stenosis in duplex ultrasound [ Time Frame: 6 and 24 months ]
  6. Change from baseline in functional status and health related quality of life (Walking Impairment Questionaire) [ Time Frame: 3 and 6 months ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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         
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         
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Investigators
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum München
Principal Investigator: Ilka Ott, MD Klinikum rechts der Isar

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT00986752     History of Changes
Other Study ID Numbers: GE IDE No. B00101
First Posted: September 30, 2009    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: January 2010

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

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