Optimal Stent Deployment Strategy of Contemporary Stents

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

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

Conditions2

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