Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease
NCT ID: NCT00986752
Last Updated: 2014-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2009-07-31
2015-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Stenting
Due to randomization one nitinol stent will be implanted after dilation with a conventional balloon.
Stenting (Smart Stent)
Nitinol stent
Stenting after PEB
Due to randomization one nitinol stent will be implanted after dilation with a Paclitaxel eluting balloon.
Stenting (Smart Stent)
Nitinol stent
Stenting after PEB (Smart Stent, Invatec)
Stenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB).
Atherectomy
The third randomization arm is Atherectomy.
Atherectomy (SilverHawk device)
Atherectomy
Interventions
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Stenting (Smart Stent)
Nitinol stent
Stenting after PEB (Smart Stent, Invatec)
Stenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB).
Atherectomy (SilverHawk device)
Atherectomy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Untreated ipsilateral iliac artery stenosis \>70%
* Previous stenting of the SFA
* Popliteal stenosis \>70%
* Severe renal insufficiency
18 Years
ALL
No
Sponsors
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Deutsches Herzzentrum Muenchen
OTHER
Responsible Party
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Principal Investigators
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Adnan Kastrati, MD
Role: STUDY_CHAIR
Deutsches Herzzentrum München
Ilka Ott, MD
Role: PRINCIPAL_INVESTIGATOR
Klinikum rechts der Isar
Locations
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Deutsches Herzzentrum
München, , Germany
I. Medizinische Klinik, Klinikum rechts der Isar
München, , Germany
Countries
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Central Contacts
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Facility Contacts
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References
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Ott I, Cassese S, Groha P, Steppich B, Hadamitzky M, Ibrahim T, Kufner S, Dewitz K, Hiendlmayer R, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH). Circulation. 2017 Jun 6;135(23):2218-2226. doi: 10.1161/CIRCULATIONAHA.116.025329. Epub 2017 Apr 19.
Other Identifiers
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GE IDE No. B00101
Identifier Type: -
Identifier Source: org_study_id
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