Nonpolymer- and Polymer-Based Drug-Eluting Stents for Restenosis (ISAR-TEST-1)
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the efficacy of nonpolymer-based rapamycin-eluting stent compared to standard polymer-based paclitaxel-eluting stent to reduce reblockage of coronary arteries.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
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.
Comparison:
Polymer-free microporous stents coated with rapamycin versus standard polymer-based, paclitaxel-eluting stents
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1 Due to randomisation patients got a Paclitaxel-eluting stent |
Device: Paclitaxel-eluting stent (Taxus)
patients has been implanted the Paclitaxel-eluting stent.
Other Names:
|
| Experimental: 2 Due to randomization patients got a Rapamycin-eluting stent. |
Device: Rapamycin-eluting stent
patients has been implanted the Rapamycin-eluting stent.
|
Outcome Measures
Primary Outcome Measures
- In-stent late luminal loss [6 months]
Secondary Outcome Measures
- Angiographic restenosis at follow-up angiography [6 months]
- Need for target lesion revascularization due restenosis at 9 months [9 months]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients at least 18 years old
-
Stable or unstable angina or a positive stress test
-
"de novo" coronary artery lesions
-
Written informed consent
Exclusion Criteria:
-
Myocardial infarction within 48 h. before enrollment
-
Target lesion located in left main trunk
-
Contraindication or known allergy to aspirin, heparin, thienopyridines, rapamycin, paclitaxel or stainless steel
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Deutsches Herzzentrum Muenchen | Munich | Germany | 80636 | |
| 2 | First Medizinische Klinik, Klinikum rechts der Isar | Munich | Germany | 81675 |
Sponsors and Collaborators
- Deutsches Herzzentrum Muenchen
- Bayerische Forschungsstiftung Muenchen
Investigators
- Study Chair: Albert Schomig, MD, Deutsches Herzzentrum Muenchen
- Principal Investigator: Adnan Kastrati, MD, Deutsches Herzzentrum Muenchen
Study Documents (Full-Text)
None provided.More Information
Publications
- Hausleiter J, Kastrati A, Wessely R, Dibra A, Mehilli J, Schratzenstaller T, Graf I, Renke-Gluszko M, Behnisch B, Dirschinger J, Wintermantel E, Schömig A; investigators of the individualizable durg-eluting Stent System to Abrogate Restenosis Project. Prevention of restenosis by a novel drug-eluting stent system with a dose-adjustable, polymer-free, on-site stent coating. Eur Heart J. 2005 Aug;26(15):1475-81. Epub 2005 Jun 23.
- Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004 Jan 15;350(3):221-31.
- Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. Epub 2004 Jan 26.
- Virmani R, Liistro F, Stankovic G, Di Mario C, Montorfano M, Farb A, Kolodgie FD, Colombo A. Mechanism of late in-stent restenosis after implantation of a paclitaxel derivate-eluting polymer stent system in humans. Circulation. 2002 Nov 19;106(21):2649-51.
- GE IDE No. S02103
- AZ 504/02