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

NCT ID: NCT01297257

Last Updated: 2014-03-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 7845 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2013-04-30

Brief Summary

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.

Conditions

Coronary Artery Disease

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Interventions

Stent implantation

Single arm, open label stent implantation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Cardiac Rhythm and Heart Failure

INDUSTRY

Sponsor Role: collaborator

Medtronic Vascular

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Onze Lieve Vrouwe Gasthuis Ziekenhuis

Amsterdam, , Netherlands

Countries

Netherlands

Other Identifiers

IP992

Identifier Type: -

Identifier Source: org_study_id