Infinity-Swedeheart Registry Based Randomized Clinical Trial (R-RCT)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronary (Artery) Disease
- Ischemic Heart Disease
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Participant)Masking Description: The patients will be blinded to the assigned device from the point of randomization onward. Study site personnel will be trained not to disclose the treatment assignment to the patient. Site personnel assigned to conduct phone follow-up visits will be provided with a standard interview script in order to reduce bias. The Clinical Event Committee will be blinded to the fullest extent possible with only redacted source documents included in the event packages.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
The Infinity-Swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor : Resolute Onyx). 2400 Patients will be randomized in Sweden. Patients will be followed at 30 days and 1 year by phone, and...
The Infinity-Swedeheart trial is a prospective, multicenter, single-blind, randomized registry-based clinical trial. Eligible patients will be randomized 1:1 (DynamX Bioadaptor : Resolute Onyx). 2400 Patients will be randomized in Sweden. Patients will be followed at 30 days and 1 year by phone, and at 6 months and 2 to 5 years through clinical and diagnostic registries.
Tracking Information
- NCT #
- NCT04562805
- Collaborators
- Uppsala University
- Investigators
- Principal Investigator: David Erlinge, MD, PhD Skane University Hospital, Lund Study Chair: Stefan James, MD, PhD Uppsala University
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