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OpenTrials
Completed

NCT Number: NCT01297257

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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Onze Lieve Vrouwe Gasthuis Ziekenhuis

Amsterdam, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stent implantation

Device

Single arm, open label stent implantation

Primary outcomes

  1. Delivery Success

    Time frame: 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 outcomes

  1. In-hospital MACE (Major Adverse Cardiac Event)

    Time frame: stent implantation until hospital discharge (average 1-3 days)

Sponsors and collaborators

Lead sponsor

Medtronic Vascular

Industry

Collaborators

  • Medtronic Cardiac Rhythm and Heart Failure

Registry information

Acronym: DELIVER

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Feb 16, 2011
Registry last updated
Mar 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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