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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01297257
Recruitment Status : Completed
First Posted : February 16, 2011
Results First Posted : March 6, 2014
Last Update Posted : March 6, 2014
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular

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.

Condition or disease Intervention/treatment
Coronary Artery Disease Device: Stent implantation

Study Type : Observational
Actual Enrollment : 7845 participants
Observational Model: Case-Only
Time Perspective: Prospective
Study Start Date : February 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : April 2013

Intervention Details:
  • Device: Stent implantation
    Single arm, open label stent implantation

Primary Outcome Measures :
  1. Delivery Success [ Time Frame: stent implantation until hospital discharge (average 1-3 days) ]
    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.

Secondary Outcome Measures :
  1. In-hospital MACE (Major Adverse Cardiac Event) [ Time Frame: stent implantation until hospital discharge (average 1-3 days) ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01297257

Onze Lieve Vrouwe Gasthuis Ziekenhuis
Amsterdam, Netherlands
Sponsors and Collaborators
Medtronic Vascular
Medtronic Bakken Research Center

Responsible Party: Medtronic Vascular Identifier: NCT01297257     History of Changes
Other Study ID Numbers: IP992
First Posted: February 16, 2011    Key Record Dates
Results First Posted: March 6, 2014
Last Update Posted: March 6, 2014
Last Verified: January 2014

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases