Evaluating stent deployment strategies for coronary artery disease

OPtimal stEnt Deployment stRategy oF Contemporary sTents

This study is testing two different ways to place stents in patients with stable coronary artery disease to see which method leads to better results.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 248 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Albert Schweitzer Hospital (Academic / other)
• Locations: 1 site (Dordrecht)
• Trial ID: NCT05292651 on ClinicalTrials.gov

What this trial studies

This study aims to compare two stent implantation techniques: a standard pre- and post-dilatation strategy versus direct stenting in patients with stable coronary artery disease. The primary objective is to determine which method results in better stent implantation outcomes as assessed by optical coherence tomography (OCT). Additionally, the study will evaluate the clinical cardiovascular outcomes associated with the pre- and post-dilatation strategy. The rationale behind this research is to address the variability in stent deployment techniques and to optimize patient outcomes based on modern stent designs and improved treatment protocols.

Who should consider this trial

Good fit: Ideal candidates include patients with stable angina or acute coronary syndrome who have significant epicardial stenosis suitable for direct stenting.

Not a fit: Patients with lesions unsuitable for direct stenting or those with acute coronary syndrome culprit lesions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved stent implantation techniques, reducing adverse cardiac events in patients with coronary artery disease.

How similar studies have performed: Previous studies have shown varying results with different stent deployment techniques, but this specific approach is novel in the context of modern stent designs.

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

Where this trial is running

Dordrecht

• Albert Schweitzer hospital — Dordrecht, Netherlands (Recruiting)

Study contacts

• Principal investigator: Rohit Oemrawsingh, MD, PhD — Albert Schweitzer Hospital
• Study coordinator: Selina Vlieger, MSc

Conditions Coronary Artery Disease