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
|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|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Active Comparator: Stenting
Due to randomization one nitinol stent will be implanted after dilation with a conventional balloon.
Device: Stenting (Smart 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)
Other Name: Smart Stent, Cordis, Johnson & JohnsonDevice: Stenting after PEB (Smart Stent, Invatec)
Stenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB).
The third randomization arm is Atherectomy.
Procedure: Atherectomy (SilverHawk device)
Other Name: SilverHawk device (EV3 Inc)
- Percentage diameter stenosis [ Time Frame: 6 months ]
- All-cause mortality [ Time Frame: 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 ]
- Time to onset of any of MAPE. [ Time Frame: 3-24 months ]
- Binary restenosis rate [ Time Frame: 6 months ]
- Percentage diameter stenosis in duplex ultrasound [ Time Frame: 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 ]
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
|Contact: Klaus Tiroch, MD||+49-89-1218 ext firstname.lastname@example.org|
|Contact: Tarek Ibrahim, MD||+49 89-1218 ext email@example.com|
|Muenchen, Germany, 80636|
|Contact: Massimiliano Fusaro, MD +49 89-1218 ext 4566 firstname.lastname@example.org|
|Contact: Tarek Ibrahim, MD +49 89-1218 ext 4016 email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Ilka Ott, MD|
|Study Chair:||Adnan Kastrati, MD||Deutsches Herzzentrum München|
|Principal Investigator:||Ilka Ott, MD||Klinikum rechts der Isar|