NCT05292651

Optimal Stent Deployment Strategy of Contemporary Stents

OPtimal stEnt Deployment stRategy oF Contemporary sTents

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 248 (estimated)
• Sponsor: Albert Schweitzer Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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, several studies found no significant difference in clinical outcome between the two different stent implantation techniques: direct stenting (DS) versus the conventional stenting after pre-dilation (CS). Consequently, the stent implantation technique has become "unprotocolarised", i.e. each operator has their own, individual set of reasons for applying or avoiding pre- and post-dilation in specific conditions. However, these trials do not apply to the current/modern clinical practice of coronary stenting. The current patient population undergoing percutaneous coronary intervention (PCI) cannot be compared to the population that was treated in the early 2000s. The same applies for stent design. Stents have undergone several major transformations in the last 20 years. Furthermore, the events rates after PCI have significantly decreased within the last decades due to better stent design and improved background pharmacological therapy. Imaging studies have revealed that an optimal stent result is not achieved in a high percentage of stent implantations. Post-hoc studies have demonstrated that the optimization of the implantation technique could reduce adverse cardiac events over time. As a result of these findings, the PSP concept: Pre-dilation, Sizing and Post-dilation was introduced. Whether routine pre- and postdilatation compared to DS also results in optimal stent implantation in contemporary drug-eluting stents (DES) has not been investigated and, hence is currently unknown. Objective: 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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
PROCEDURE	PCI	percutaneous coronary intervention

Timeline

• Start date: 2022-09-01
• Primary completion: 2027-09-01
• Completion: 2029-09-01
• First posted: 2022-03-23
• Last updated: 2024-02-01

Locations

1 site across 1 country: Netherlands