Actively Recruiting
Optimal Stent Deployment Strategy of Contemporary Stents
Led by Albert Schweitzer Hospital · Updated on 2024-02-01
248
Participants Needed
1
Research Sites
365 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective is to evaluate whether a standard pre- and postdilatation (PSP strategy) of the modern DES results in a more optimal stent implantation compared to DS as evaluated by OCT in patients with stable coronary artery disease. The secondary clinical objective is to evaluate clinical cardiovascular outcomes in patients with stable coronary artery disease treated with the PSP strategy.
CONDITIONS
Official Title
Optimal Stent Deployment Strategy of Contemporary Stents
Who Can Participate
Eligibility Criteria
You may qualify if you...
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Stable angina patients or acute coronary syndrome patients with bystander stable coronary artery disease
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With one or more significant epicardial stenosis in native coronary arteries suitable for direct stenting, according to the judgement of treating operator.
The use of fractional flow reserve (FFR) or resting indices like iFR and RFR to assess lesion severity is encouraged.
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Subject must be at least 18 years of age
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Written consent to participate in the study
You will not qualify if you...
- Lesions not suitable for direct stenting, like (sub)-total stenosis, severely calcified lesions
- Culprit lesions of acute coronary syndrome cannot be randomized to the trial. After successful treatment of the ACS culprit lesion, patients however can be randomized in the trial in case of remaining stable non-culprit lesions that thought to be stented directly of during a staged procedure.
- Lesions not suitable for OCT catheter delivery and imaging, e.g. left main or ostial right coronary artery stenosis, lesions in coronary bypass grafts or tortuous anatomy
- Treatment for in-stent restenosis
- Bifurcation lesions in which a two-stent technique or a proximal postdilatation is planned.
- Treatment of coronary artery bypass grafts
- Creatine Clearance ≤ 30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR)
- Known hypersensitivity or allergy for cobalt chromium
- Known comorbidity associated with a life expectancy < 1 year
- Unable to understand and follow study-related instructions or unable to comply with study protocol
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Albert Schweitzer hospital
Dordrecht, Netherlands
Actively Recruiting
Research Team
S
Selina Vlieger, MSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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