DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting

Medtronic Vascular7,845 enrolled

Overview

The primary objective of the DELIVER Study is to assess the deliverability of the Resolute Integrity Stent as primary stent or as a secondary cross-over stent following delivery failure of another stent type in real world patients.

Study Type

OBSERVATIONAL

Enrollment

7,845

Conditions

Coronary Artery Disease

Interventions

Stent implantationDEVICE

Single arm, open label stent implantation

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Minimum legal age (18) * Acceptable candidate for treatment with a drug-eluting stent in accordance with applicable guidelines * Patient has consented to participate and authorized in writing the collection and release of medical information Exclusion Criteria: * Pregnancy * Participating in another study that interferes with study endpoints * Untreatable hypersensitivity or allergies to aspirin, heparin, clopidogrel, zotarolimus or similar drugs or contrast media * Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated

Locations (1)

Onze Lieve Vrouwe Gasthuis Ziekenhuis

Amsterdam, Netherlands

Outcomes

Primary Outcomes

Delivery Success

The primary endpoint for this study is delivery success defined as complete passage of the Resolute Integrity stent across the target lesion with full expansion of the stent to the desired diameter at the desired location.

Time frame: stent implantation until hospital discharge (average 1-3 days)

Secondary Outcomes

In-hospital MACE (Major Adverse Cardiac Event)

Time frame: stent implantation until hospital discharge (average 1-3 days)

Data from ClinicalTrials.gov

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