OPtimal stEnt deployment stRategy oF Contemporary sTents

Recruiting

• Conditions: coronary artery disease; 10011082

• Registration Number: NL-OMON51377
• Lead Sponsor: Albert Schweitzer Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 247

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
11. Known comorbidity associated with a life expectancy < 1 year

Study & Design

• Study Type: Interventional
• Study Design: Not specified