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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01297257
First Posted: February 16, 2011
Last Update Posted: March 6, 2014
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.
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular
December 20, 2010
February 16, 2011
November 20, 2013
March 6, 2014
March 6, 2014
February 2011
October 2012   (Final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01297257 on ClinicalTrials.gov Archive Site
In-hospital MACE (Major Adverse Cardiac Event) [ Time Frame: stent implantation until hospital discharge (average 1-3 days) ]
Same as current
Not Provided
Not Provided
 
DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting
Not Provided
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.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
Coronary Artery Disease
Device: Stent implantation
Single arm, open label stent implantation
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7845
April 2013
October 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT01297257
IP992
No
Not Provided
Not Provided
Medtronic Vascular
Medtronic Vascular
Medtronic Bakken Research Center
Not Provided
Medtronic Vascular
January 2014