Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Medtronic Bakken Research Center
Information provided by (Responsible Party):
Medtronic Vascular
ClinicalTrials.gov Identifier:
NCT01297257
First received: December 20, 2010
Last updated: January 21, 2014
Last verified: January 2014

December 20, 2010
January 21, 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) ] [ Designated as safety issue: No ]
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) ] [ Designated as safety issue: Yes ]
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01297257
IP992
No
Medtronic Vascular
Medtronic Vascular
Medtronic Bakken Research Center
Not Provided
Medtronic Vascular
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP