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

Coronary Artery Disease Clinical Trial

— DELIVER  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01297257
• Other study ID #: IP992
• Status: Completed
• Phase: N/A
• First received: December 20, 2010
• Last updated: January 21, 2014
• Start date: February 2011
• Est. completion date: April 2013

Study information

• Verified date: January 2014
• Source: Medtronic Vascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministry of HealthIsrael: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7845
• Est. completion date: April 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Netherlands	Onze Lieve Vrouwe Gasthuis Ziekenhuis	Amsterdam

Sponsors (2)

Lead Sponsor	Collaborator
Medtronic Vascular	Medtronic Bakken Research Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delivery Success	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.	stent implantation until hospital discharge (average 1-3 days)	No
Secondary	In-hospital MACE (Major Adverse Cardiac Event)		stent implantation until hospital discharge (average 1-3 days)	Yes