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
  Purpose

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 Intervention
Coronary Artery Disease
Device: Stent implantation

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Medtronic Vascular:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • In-hospital MACE (Major Adverse Cardiac Event) [ Time Frame: stent implantation until hospital discharge (average 1-3 days) ] [ Designated as safety issue: Yes ]

Enrollment: 7845
Study Start Date: February 2011
Study Completion Date: April 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Stent implantation
    Single arm, open label stent implantation
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01297257

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

No publications provided

Responsible Party: Medtronic Vascular
ClinicalTrials.gov Identifier: NCT01297257     History of Changes
Other Study ID Numbers: IP992
Study First Received: December 20, 2010
Results First Received: November 20, 2013
Last Updated: January 21, 2014
Health Authority: Italy: Ministry of Health
Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on July 29, 2014