Optimal Stent Deployment Strategy of Contemporary Stents

NCT ID: NCT05292651

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 248 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2029-09-01

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

PSP technique

The definitions of the PSP technique are:

• Predilatation is mandatory with a balloon diameter equal to or maximally 0.5 mm less than the distal reference vessel diameter. We hypothesize that this lesion preparation and fracture of the calcium may result in better stent apposition, less recoil and higher minimal stent area (MSA) Also see endpoints.
• The DES should be deployed at 2 atm. above the nominal pressure. This relatively low stent deployment pressure may prevent stent edge dissections.
• The postdilatation is mandatory with a shorter length and (at least 0.25mm) larger diameter non-compliant balloon at 16 atm. The apposition, minimal stent area (MSA) and recoil may improve with this large, high pressure postdilatation. The slightly shorter balloon can prevent edge dissections.

Group Type: EXPERIMENTAL

PCI

Intervention Type: PROCEDURE

percutaneous coronary intervention

Direct Stenting

• The DES is directly placed without any lesion preparation and deployed at a pressure at the discretion of the operator. Ideally a pressure would be achieved in which angiographic expansion of the DES is complete (without significant dog-boning)

Group Type: ACTIVE_COMPARATOR

PCI

Intervention Type: PROCEDURE

percutaneous coronary intervention

Interventions

PCI

percutaneous coronary intervention

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Albert Schweitzer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Rohit M. Oemrawsingh

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rohit Oemrawsingh, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Albert Schweitzer Hospital

Locations

Albert Schweitzer hospital

Dordrecht, , Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Selina Vlieger, MSc

Role: CONTACT

s.vlieger@asz.nl

0786541492

Other Identifiers

PERFECT 001

Identifier Type: -

Identifier Source: org_study_id