Nonpolymer- and Polymer-Based Drug-Eluting Stents for Restenosis (ISAR-TEST-1)
|ClinicalTrials.gov Identifier: NCT00140530|
Recruitment Status : Completed
First Posted : September 1, 2005
Last Update Posted : January 11, 2008
|Condition or disease||Intervention/treatment||Phase|
|Coronary Disease||Device: Paclitaxel-eluting stent (Taxus) Device: Rapamycin-eluting stent||Phase 4|
Drug-eluting stents represent a major advance in the treatment of restenosis. They have dramatically reduced the need of repeat revascularization procedures, and, thanks to the excellent results obtained in various patient subsets, these devices are now used in almost 90% of the stent implantation procedures performed in US hospitals. Along with the increasing number of patients receiving drug-eluting stents and availability of long-term follow-up data, concern has arisen regarding the safety of these devices. At the core of this concern is the potential for increased inflammatory and thrombogenic responses and their life-threatening consequences associated with the polymers employed for the delivery of antirestenotic agents. A growing interest has been shown on polymer-free stents with a microporous surface as an alternative to stents employing polymeric coating for local drug delivery. Recently, we developed a mobile system which enables coating in the catheterization laboratory of polymeric free stents with different drug doses or combinations. Using a porcine coronary model of restenosis, we found that coating with rapamycin of a polymer-free microporous stent is feasible and effectively reduces neointimal proliferation. More recently, in a clinical study in which the efficacy of several doses of rapamycin was assessed, we showed that non-polymer coating with rapamycin is safe and leads to a dose-dependent reduction in restenosis. While the advantage deriving from the lack of polymeric cover in on-site coated rapamycin-eluting stents is readily understandable, their relative efficacy as compared with commercially available polymer-based drug-eluting stents has yet to be evaluated.
Polymer-free microporous stents coated with rapamycin versus standard polymer-based, paclitaxel-eluting stents
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||450 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of a Nonpolymer-Based Rapamycin-Eluting Stent Versus a Polymer-Based Paclitaxel-Eluting Stent for the Prevention of Restenosis (ISAR-TEST-1)|
|Study Start Date :||March 2004|
|Study Completion Date :||June 2005|
Due to randomisation patients got a Paclitaxel-eluting stent
Device: Paclitaxel-eluting stent (Taxus)
patients has been implanted the Paclitaxel-eluting stent.
Other Name: Taxus
Due to randomization patients got a Rapamycin-eluting stent.
Device: Rapamycin-eluting stent
patients has been implanted the Rapamycin-eluting stent.
- In-stent late luminal loss [ Time Frame: 6 months ]
- Angiographic restenosis at follow-up angiography [ Time Frame: 6 months ]
- Need for target lesion revascularization due restenosis at 9 months [ Time Frame: 9 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00140530
|Deutsches Herzzentrum Muenchen|
|Munich, Germany, 80636|
|First Medizinische Klinik, Klinikum rechts der Isar|
|Munich, Germany, 81675|
|Study Chair:||Albert Schomig, MD||Deutsches Herzzentrum Muenchen|
|Principal Investigator:||Adnan Kastrati, MD||Deutsches Herzzentrum Muenchen|