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: April 30, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	December 20, 2010
Last Updated Date	April 30, 2013
Start Date ^ICMJE	February 2011
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 15, 2011)	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.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01297257 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 15, 2011)	In-hospital MACE (Major Adverse Cardiac Event) [ Time Frame: stent implantation until hospital discharge (average 1-3 days) ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting
Official Title ^ICMJE	Not Provided
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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 stenoses that are amenable to percutaneous treatment.
Condition ^ICMJE	Coronary Artery Disease
Intervention ^ICMJE	Device: Stent implantation Single arm, open label stent implantation
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	8846
Completion Date	April 2013
Primary Completion Date	October 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Netherlands

Administrative Information
NCT Number ^ICMJE	NCT01297257
Other Study ID Numbers ^ICMJE	IP992
Has Data Monitoring Committee	No
Responsible Party	Medtronic Vascular
Study Sponsor ^ICMJE	Medtronic Vascular
Collaborators ^ICMJE	Medtronic Bakken Research Center
Investigators ^ICMJE	Not Provided
Information Provided By	Medtronic Vascular
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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