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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: rapamycin-eluting Stent with permanent polymer
* Device: rapamycin-eluting stent with biodegradable polymer
* Device: polymer-free, rapamycin-eluting stent


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Drug eluting stent using biodegradable polymer BP stent | Device: rapamycin-eluting stent with biodegradable polymer<br>* due to randomization, rapamycin-eluting stent with biodegradable polymer will be implanted<br>|
| Active Comparator: B<br>polymer-free drug eluting stent PF stent | Device: polymer-free, rapamycin-eluting stent<br>* due to randomization, polymer-free.rapamycin-eluting stent will be implanted<br>|
| Active Comparator: C<br>permanent polymer using stents PP stent | Device: rapamycin-eluting Stent with permanent polymer<br>* due to randomization, rapamycin-eluting stent with permanent polymer will be implanted<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-stent late luminal loss |  | at 6 to 8-month follow-up angiogram | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-segment binary angiographic restenosis |  | at 6 to 8-month follow-up angiogram | 
| Need of target lesion revascularization |  | at 9-month follow-up | 
| Combined incidence of death or myocardial infarction |  | at 9-month follow-up | 
| Incidence of stent thrombosis. |  | at 9-month follow-up |