DELIVER Study: DELiverability of the Resolute Integrity Stent in All-Comer Vessels and Cross-OvER Stenting
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01297257
- Lead Sponsor
- Medtronic Vascular
- 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 available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7845
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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Delivery Success 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.
- Secondary Outcome Measures
Name Time Method In-hospital MACE (Major Adverse Cardiac Event) stent implantation until hospital discharge (average 1-3 days)
Trial Locations
- Locations (1)
Onze Lieve Vrouwe Gasthuis Ziekenhuis
🇳🇱Amsterdam, Netherlands
Onze Lieve Vrouwe Gasthuis Ziekenhuis🇳🇱Amsterdam, Netherlands