Optimal Stent Deployment Strategy of Contemporary Stents

NCT05292651 | Recruiting DMC

• 1 other identifier: PERFECT 001
• Study Type: interventional
• Target: 248
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Suboptimal stent results which is defined as a composite of major stent underexpansion and major edge dissection measured by OCT at lesion level directly after completion of the stent implantation according to the protocol

  Stent malapposition (categorical variable) is defined as: * Unacceptable stent expansion: The minimal stent area (MSA) of the proximal segment is \<90% of the proximal lumen area, and/or the MSA of the distal segment is \<90% of the distal reference lumen area on OCT OR * Presence of incompletely apposed stent struts on OCT more than 3mm long (defined as stent struts clearly separated from the vessel wall (lumen border/plaque border) without any tissue behind the struts with a distance from the adjacent intima of ≥0.2 mm and not associated with any side branch: i.e. the Prati criterium) Edge dissections (categorical variable) will be presented as: • Dissections on OCT of ≥60 degrees of the circumference of the vessel at the site of dissection and ≥3 mm in length

  During procedure

Secondary Outcomes (12)

• Minimal stent area (MSA) (mm^2)

  During procedure

• Acute recoil (percent)

  During procedure

• Stent malapposition (percent)

  During procedure

• Mean stent expansion (percent):

  During procedure

• Intra-stent plaque protrusion and thrombus

  During procedure

Study Arms (2)

PSP technique

EXPERIMENTAL

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.

Procedure: PCI

Direct Stenting

ACTIVE COMPARATOR

• 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)

Procedure: PCI

Interventions

PCI PROCEDURE

percutaneous coronary intervention

Direct Stenting; PSP technique

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stable angina patients or acute coronary syndrome patients with bystander stable coronary artery disease
• 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.
• Subject must be at least 18 years of age
• Written consent to participate in the study

You may not qualify if:

• Lesions not suitable for direct stenting, like (sub)-total stenosis, severely calcified lesions
• 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.
• 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
• Treatment for in-stent restenosis
• Bifurcation lesions in which a two-stent technique or a proximal postdilatation is planned.
• Treatment of coronary artery bypass grafts
• Creatine Clearance ≤ 30 ml/min/1.73 m2 (as calculated by MDRD formula for estimated GFR)
• Known hypersensitivity or allergy for cobalt chromium
• Known comorbidity associated with a life expectancy \< 1 year
• Unable to understand and follow study-related instructions or unable to comply with study protocol

Sponsors & Collaborators

• Albert Schweitzer Hospital: lead

Study Sites (1)

Albert Schweitzer hospital

Dordrecht, Netherlands

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Rohit Oemrawsingh, MD, PhD

  Albert Schweitzer Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Selina Vlieger, MSc

CONTACT

0786541492; s.vlieger@asz.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: single-center, prospective, single blinded randomized clinical trial

Study Record Dates

• First Submitted: December 2, 2021
• First Posted: March 23, 2022
• Study Start: September 1, 2022
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)