Status:
RECRUITING
Optimal Stent Deployment Strategy of Contemporary Stents
Lead Sponsor:
Albert Schweitzer Hospital
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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 pati...
Detailed Description
Rationale: Historically, when coronary stents were initially introduced, the standard and mandatory treatment of a significant stenosis was with pre-dilation prior to stent placement. In the 2000s, se...
Eligibility Criteria
Inclusion
- Stable angina patients or acute coronary syndrome patients with bystander stable coronary artery disease
- 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.
- Subject must be at least 18 years of age
- Written consent to participate in the study
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2029
Estimated Enrollment :
248 Patients enrolled
Trial Details
Trial ID
NCT05292651
Start Date
September 1 2022
End Date
September 1 2029
Last Update
February 1 2024
Active Locations (1)
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1
Albert Schweitzer hospital
Dordrecht, Netherlands