NCT00350454

Rapamycin-Eluting Stents With Different Polymer Coating to Reduce Restenosis (ISAR-TEST-3)

Prospective, Randomized Trial of 3 Rapamycin-Eluting Stents With Different Polymer Coating Strategies For The Reduction of Coronary Restenosis (ISAR-TEST-3)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 605 (actual)
• Sponsor: Deutsches Herzzentrum Muenchen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the efficacy of 3 different rapamycin-eluting-stent platforms to reduce coronary artery reblockage after stent implantation

Detailed description

Coronary artery reblockage remains still a drawback of percutaneous coronary interventions even in the era of drug-eluting stents (DES). DESs working principle consists of the delivery of controlled amounts of antiproliferative agents at the local level, which results in the suppression of neointimal proliferation, the main cause of lumen re-narrowing after stent implantation. At present, several DES platforms have been developed and evaluated for clinical use. They differ between them with regard to the stent type, anti-proliferative drug, presence of polymers employed for drug storage and modification of drug-release kinetics as well as type of polymer used for this purpose. Although their mid-term efficacy has been well-established, there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with DESs. Based on animal and human pathological data, investigators have linked the above-mentioned concerns to the presence of polymers in DESs, which have a proinflammatory and prothrombinogenic potential, and sometimes may induce a hypersensitivity reaction. This trial will compare the anti-restenotic efficacy of the permanent polymer (PP), biodegradable polymer (BP) and polymer-free (PF) rapamycin-eluting stents in patients with coronary artery disease. Cypher stent (PP) is a stainless steel stent coated with sirolimus with use of permanent polymers while the ISAR stent is a rough surface stainless steel stent which allows not only polymeric coating (for example biodegradable polymer, BP ISAR stent) but also coating without the need of polymer (PF ISAR stent) in the cath lab.

Conditions

• Coronary Heart Disease

Interventions

Type	Name	Description
DEVICE	rapamycin-eluting Stent with permanent polymer	due to randomization, rapamycin-eluting stent with permanent polymer will be implanted
DEVICE	rapamycin-eluting stent with biodegradable polymer	due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted
DEVICE	polymer-free, rapamycin-eluting stent	due to randomization, polymer-free.rapamycin-eluting stent will be implanted

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-09-01
• Completion: 2007-10-01
• First posted: 2006-07-10
• Last updated: 2008-01-11

Locations

2 sites across 1 country: Germany