3 Limus Agent Eluting Stents With Different Polymer Coating (ISAR-TEST-4)

German Heart Center Munich

Status and phase: Completed; Phase 4

Conditions: Coronary Heart Disease

Treatments: Device: biodegradable polymer Rapamycin-eluting stent; Device: permanent polymer everolimus-eluting stent (Xience, Promus); Device: permanent polymer rapamycin-eluting stent (Cypher)

Study type: Interventional

Funder types: Other

Identifiers

NCT00598676

GE IDE No. S02607

Details and patient eligibility

About

The aim of this study is to determine whether biodegradable polymer based rapamycin-eluting stent performs equal to permanent polymer based everolimus- and rapamycin-eluting stents regarding reduction of adverse cardiac events at one year.

Full description

Drug-eluting stents significantly reduce in-stent restenosis and the subsequent need for target vessel revascularisation compared with bare metal stents. Although this applies to the vast majority of patients, intimal hyperplasia and in-stent restenosis have not been completely eliminated and remain to occur in certain high risk subgroups. Thus there is ongoing research for new, potentially more effective and safe drug-eluting stent systems.

One direction of extensive research is the search of new polymers such as biodegradable polymers which allow a controlled drug-release and disappear with time, reducing the probability of polymer-induced chronic inflammation on the vessel wall.

Another direction is finding new drugs to suppress neointimal hyperplasia. Promising preclinical and clinical results suggest that the Everolimus eluting stent platform might provide potential improvements over prior generations of drug-eluting stents.

Enrollment: 2,600 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• In women with childbearing potential a negative pregnancy test is mandatory

Exclusion criteria

• Target lesion located in the left main trunk.
• Target lesion located in the 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: Clopidogrel, Rapamycin, Everolimus, stainless steel or cobalt chrome.
• Inability to take clopidogrel for at least 6 months.
• Pregnancy (present, suspected or planned) or positive pregnancy test.
• Previous enrollment in this trial.
• Patient's inability to fully cooperate with the study protocol

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,600 participants in 3 patient groups

BPRES

Experimental group

Description:

biodegradable polymer rapamycin-eluting stent

Treatment:

Device: biodegradable polymer Rapamycin-eluting stent

PPRES

Active Comparator group

Description:

permanent polymer rapamycin-eluting stent

Treatment:

Device: permanent polymer rapamycin-eluting stent (Cypher)

PPEES

Active Comparator group

Description:

permanent polymer everolimus-eluting stent

Treatment:

Device: permanent polymer everolimus-eluting stent (Xience, Promus)