Clinical trial NCT00350454: Rapamycin-Eluting Stents With Different Polymer Coating to Reduce Restenosis (ISAR-TEST-3)
Official title: Prospective, Randomized Trial of 3 Rapamycin-Eluting Stents With Different Polymer Coating Strategies For The Reduction of Coronary Restenosis (ISAR-TEST-3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Coronary Heart Disease
Lead sponsor: Deutsches Herzzentrum Muenchen
Sponsor class: OTHER
First posted: 2006-07-10
Enrollment: 605
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Patients older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥50% de novo stenosis located in native coronary vessels.
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.

Exclusion Criteria:

* Target lesion located in the left main trunk or bypass graft.
* In-stent restenosis.
* Cardiogenic shock.
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Known allergy to the study medications: aspirin, clopidogrel, rapamycin, stainless steel.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.

Primary outcomes:
measure: in-stent late luminal loss
timeFrame: at 6 to 8-month follow-up angiogram
Secondary outcomes:
measure: In-segment binary angiographic restenosis
timeFrame: at 6 to 8-month follow-up angiogram
measure: Need of target lesion revascularization
timeFrame: at 9-month follow-up
measure: Combined incidence of death or myocardial infarction
timeFrame: at 9-month follow-up
measure: Incidence of stent thrombosis.
timeFrame: at 9-month follow-up
Other outcomes:
Locations:
city: Muenchen
country: Germany
facility: 1. Medizinische Klinik, Klinikum rechts der Isar
city: Munich
country: Germany
facility: Deutsches Herzzentrum Muenchen
Study officials:
affiliation: Deutsches Herzzentrum Muenchen
name: Albert Schoemig, MD
role: STUDY_CHAIR
affiliation: Deutsches Herzzentrum Muenchen
name: Adnan Kastrati, MD
role: PRINCIPAL_INVESTIGATOR
References:
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