DUrable Polymer-based STent CHallenge of Promus Element Versus ReSolute Integrity in an All Comers Population

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

1811 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-12-31

Brief Summary

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The introduction of drug-eluting stents (DES) in the treatment of coronary artery disease has led to a significant reduction in morbidity but there are further demands on DES performance. Such demands are an optimized performance in very challenging coronary lesions; third generation DES were developed in an effort to further improve DES performance in such challenging lesions. Two CE-certified third generation DES (Resolute Integrity and Promus Element stents) are currently available; there are no data that indicate an advantage of one of these DES over the other.

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Detailed Description

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Conditions

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Acute Coronary Syndrome Angina Pectoris Angina, Unstable Myocardial Infarction Coronary Artery Disease Coronary Stenosis Coronary Restenosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Promus Element

Group Type ACTIVE_COMPARATOR

Promus Element (Everolimus-eluting stent)

Intervention Type DEVICE

Third generation drug-eluting stent

Resolute Integrity

Group Type ACTIVE_COMPARATOR

Resolute Integrity (Zotarolimus-eluting stent)

Intervention Type DEVICE

Third generation drug-eluting stent

Interventions

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Resolute Integrity (Zotarolimus-eluting stent)

Third generation drug-eluting stent

Intervention Type DEVICE

Promus Element (Everolimus-eluting stent)

Third generation drug-eluting stent

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Minimum age of 18 years;
* Coronary artery disease and lesion(s) eligible for treatment with drug eluting stents according to clinical guidelines and/or the operators' judgement;
* Patient is willing and able to cooperate with study procedures and required follow-up visits; and patient has been informed and agrees on the participation by signing an EC approved written informed consent.

Exclusion Criteria

* Participation in another randomized drug or device study before reaching primary endpoint;
* Planned surgery within 6 months of PCI unless dual antiplatelet therapy is maintained throughout the peri-surgical period;
* Intolerance to a P2Y12 receptor antagonist that results in the patient's inability to adhere to dual-antiplatelet therapy, or intolerance to aspirin, heparin, or components of the two DES examined;
* Known pregnancy;
* Life expectancy of less than 1 year.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No