Optimal Stent Deployment Strategy of Contemporary Stents

Coronary Artery Disease Clinical Trial

— PERFECTPSP  

Official title:

OPtimal stEnt Deployment stRategy oF Contemporary sTents

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05292651
• Other study ID #: PERFECT 001
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: September 1, 2029

Study information

• Verified date: January 2024
• Source: Albert Schweitzer Hospital
• Contact: Selina Vlieger, MSc
• Phone: 0786541492
• Email: s.vlieger[@]asz.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 248
• Est. completion date: September 1, 2029
• Est. primary completion date: September 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Procedure:
• PCI
percutaneous coronary intervention

Locations

Country	Name	City	State
Netherlands	Albert Schweitzer hospital	Dordrecht

Sponsors (1)

Lead Sponsor	Collaborator
Albert Schweitzer Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Minimal stent area (MSA) (mm^2)		During procedure
Secondary	Acute recoil (percent)	assessed on coronary angiography	During procedure
Secondary	Stent malapposition (percent)	defined as frequency of incompletely apposed stent struts (defined as stent struts clearly separated from the vessel wall (lumen border/plaque surface) without any tissue behind the struts with a distance from the adjacent intima of =0.2 mm and not associated with any side branch).	During procedure
Secondary	Mean stent expansion (percent):	mean stent area (stent volume/analysed stent length) divided by the average of proximal and distal reference lumen areas x 100	During procedure
Secondary	Intra-stent plaque protrusion and thrombus	defined as any intraluminal mass protruding at least 0.2 mm within the luminal edge of a stent strut	During procedure
Secondary	Post OCT stent result optimalization (percent)	composite of additional post-dilation and/or stent placements after OCT	During procedure
Secondary	MACE	a composite of time- to-first event rate of cardiac death, target vessel MI, ischemia-driven target vessel revascularization (TVR)	1-,3- and 5-year follow-up
Secondary	Target Lesion Failure (TLF)	defined as cardiac death, target vessel- myocardial infarction and clinically indicated target lesion revascularization)	1-,3- and 5-year follow-up
Secondary	Target Vessel Failure (TVF)	defined as cardiac death, target vessel- myocardial infarction and clinically indicated target vessel revascularization	1-,3- and 5-year follow-up
Secondary	All cause mortality		1-,3- and 5-year follow-up
Secondary	Stent Thrombosis	definite or probable; Academic Research Consortium (ARC) definition	1-,3- and 5-year follow-up
Secondary	Cost-effectiveness analysis	total number of stent, balloons, wires and repeat hospitalizations due to MACE	1-,3- and 5-year follow-up