Clinical trial NCT05292651: Optimal Stent Deployment Strategy of Contemporary Stents
Official title: OPtimal stEnt Deployment stRategy oF Contemporary sTents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Lead sponsor: Albert Schweitzer Hospital
Sponsor class: OTHER
First posted: 2022-03-23
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-center, prospective, single blinded randomized clinical trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: 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
timeFrame: During procedure
Secondary outcomes:
measure: Minimal stent area (MSA) (mm^2)
timeFrame: During procedure
measure: Acute recoil (percent)
timeFrame: During procedure
measure: Stent malapposition (percent)
timeFrame: During procedure
measure: Mean stent expansion (percent):
timeFrame: During procedure
measure: Intra-stent plaque protrusion and thrombus
timeFrame: During procedure
measure: Post OCT stent result optimalization (percent)
timeFrame: During procedure
measure: MACE
timeFrame: 1-,3- and 5-year follow-up
measure: Target Lesion Failure (TLF)
timeFrame: 1-,3- and 5-year follow-up
measure: Target Vessel Failure (TVF)
timeFrame: 1-,3- and 5-year follow-up
measure: All cause mortality
timeFrame: 1-,3- and 5-year follow-up
measure: Stent Thrombosis
timeFrame: 1-,3- and 5-year follow-up
measure: Cost-effectiveness analysis
timeFrame: 1-,3- and 5-year follow-up
Other outcomes:
Locations:
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer hospital
Study officials:
affiliation: Albert Schweitzer Hospital
name: Rohit Oemrawsingh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: