QUantitative Flow Ratio Or Angiography for the assessMent of nOn-culprit Lesions
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Coronary (Artery) Disease
- Type
- Interventional
- Phase
- Phase 4
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Patients will be randomized 1:1 to one of the two study arms. Randomization will be done by using a computer-generated random sequence (Medcalc, Mariakerke, BE).Masking: Double (Participant, Outcomes Assessor)Masking Description: Patients and outcome assessors will be blinded to the randomization group.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
The study is a single-center, randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions. The primary analysis will be on the per-protocol principle (i.e. including all patients who are not protocol violators). A separate analysis will ...
The study is a single-center, randomized superiority trial to compare two strategies for the assessment of the hemodynamic relevance of coronary lesions. The primary analysis will be on the per-protocol principle (i.e. including all patients who are not protocol violators). A separate analysis will be performed on an intention-to-treat basis (i.e. all randomized patients randomized to a treatment arm). Primary endpoint 1. Angina questionnaire Secondary endpoints: Number and % of patients undergoing PCI Seattle Angina Questionnaire SAQ Physical limitation scale SAQ angina stability scale SAQ angina frequency scale SAQ quality of life SAQ Treatment Satisfaction Disease perception scale Follow-up (3 and 12 months) - Patient-oriented composite endpoint (death, myocardial infarction, unplanned revascularization) and its components.
Tracking Information
- NCT #
- NCT04808310
- Collaborators
- Not Provided
- Investigators
- Not Provided
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