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

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 Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Stent implantation

• Study Type: Observational
• Enrollment (Actual): 7845

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Onze Lieve Vrouwe Gasthuis Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients with symptomatic ischemic heart disease due to stenotic lesions in coronary arteries or bypass graft that are amenable to percutaneous treatment.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	stent implantation until hospital discharge (average 1-3 days)

Secondary Outcome Measures

Outcome Measure	Time Frame
In-hospital MACE (Major Adverse Cardiac Event)	stent implantation until hospital discharge (average 1-3 days)

Collaborators and Investigators

• Sponsor: Medtronic Vascular
• Collaborators: Medtronic Bakken Research Center

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): October 1, 2012
• Study Completion (Actual): April 1, 2013

Study Registration Dates

• First Submitted: December 20, 2010
• First Submitted That Met QC Criteria: February 15, 2011
• First Posted (Estimate): February 16, 2011

Study Record Updates

• Last Update Posted (Estimate): March 6, 2014
• Last Update Submitted That Met QC Criteria: January 21, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: IP992