An Evaluation of the Commercially Available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
Not Applicable
Completed
- Conditions
- Coronary Artery Disease
- Registration Number
- NCT01638507
- Lead Sponsor
- Medtronic Vascular
- Brief Summary
The purpose of this post approval study is to conduct a prospective, multicenter evaluation of the procedural and clinical outcomes of subjects that are treated with the commercially available Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System.
- Detailed Description
The purpose and objective is to assess the safety and efficacy of the Resolute Integrity Stent for the treatment of de novo lesions in native coronary arteries with a reference vessel diameter(RD) of 2.25mm to 4.2mm in two groups of patients, specifically those patients receiving stents less than or equal to 30mm in length.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 230
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Composite Rate of Cardiac Death and Target Vessel Myocardial Infarction (MI) 12 months
- Secondary Outcome Measures
Name Time Method Clinical Endpoint: TLR 12 months Clinical Endpoint: ST 12 months Composite Endpoints: Major Adverse Cardiac Events (MACE), Target Lesion Failure (TLF), Target Vessel Failure (TVF), Cardiac Death and Target Vessel MI 12 months Clinical Endpoint: Death 12 months Dual Antiplatelet Therapy (DAPT) Compliance 12 months Clinical Endpoint: Stroke 12 months Clinical Endpoint: MI 12 months Clinical Endpoint: Bleeding Complications in General 12 months Clinical Endpoint: TVR 12 months
Trial Locations
- Locations (1)
St. Joseph's Hospital Health Center
🇺🇸Syracuse, New York, United States
St. Joseph's Hospital Health Center🇺🇸Syracuse, New York, United States