NCT05292651 Optimal Stent Deployment Strategy of Contemporary Stents
| NCT ID | NCT05292651 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Albert Schweitzer Hospital |
| Condition | Coronary Artery Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 248 participants |
| Start Date | 2022-09-01 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 248 participants in total. It began in 2022-09-01 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Eligibility Criteria
Inclusion Criteria: 1. Stable angina patients or acute coronary syndrome patients with bystander stable coronary artery disease 2. 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. 3. Subject must be at least 18 years of age 4. Written consent to participate in the study Exclusion Criteria: 1. Lesions not suitable for direct stenting, like (sub)-total stenosis, severely calcified lesions 2. 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. 3. 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 4. Treatment for in-stent restenosis 5. Bifurcation lesions in which a two-stent technique or a proximal postdilatation is planned. 6. Treatment of coronary artery bypass grafts 7. Creatine Clearance ≤ 30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR) 8. Known hypersensitivity or allergy for cobalt chromium 9. Known comorbidity associated with a life expectancy \< 1 year 10. Unable to understand and follow study-related instructions or unable to comply with study protocol
Contact & Investigator
Rohit Oemrawsingh, MD, PhD
PRINCIPAL INVESTIGATOR
Albert Schweitzer Hospital
Frequently Asked Questions
Who can join the NCT05292651 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Coronary Artery Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05292651 currently recruiting?
Yes, NCT05292651 is actively recruiting participants. Contact the research team at s.vlieger@asz.nl for enrollment information.
Where is the NCT05292651 trial being conducted?
This trial is being conducted at Dordrecht, Netherlands.
Who is sponsoring the NCT05292651 clinical trial?
NCT05292651 is sponsored by Albert Schweitzer Hospital. The principal investigator is Rohit Oemrawsingh, MD, PhD at Albert Schweitzer Hospital. The trial plans to enroll 248 participants.