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

NCT01297257 | Completed Results

• 1 other identifier: IP992
• Study Type: observational
• Target: 7,845
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• In-hospital MACE (Major Adverse Cardiac Event)

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

Interventions

Stent implantation DEVICE

Single arm, open label stent implantation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Vascular: lead
• Medtronic Cardiac Rhythm and Heart Failure: collaborator

Study Sites (1)

Onze Lieve Vrouwe Gasthuis Ziekenhuis

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Frank van Leeuwen, M.D.
• Organization: Clinical Research Director

frank.van.leeuwen@medtronic.com

+31433566622

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2010
• First Posted: February 16, 2011
• Study Start: February 1, 2011
• Primary Completion: October 1, 2012
• Study Completion: April 1, 2013
• Last Updated: March 6, 2014
• Results First Posted: March 6, 2014

Record last verified: 2014-01

Locations

NL (1)