Coronary Artery DiseasePERFECTPSPNCT05292651
Optimal Stent Deployment Strategy of Contemporary Stents
A study testing PCI in people with Coronary Artery Disease, run by Albert Schweitzer Hospital at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PCI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Sep 2022to 1 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
Albert Schweitzer hospital
Dordrecht
About this study
Official title: OPtimal stEnt Deployment stRategy oF Contemporary sTents
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.
Read the 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
- Being tested
- PCI
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIProcedure or surgery
percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Procedure: PCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During procedure
Secondary outcomes (12)
Minimal stent area (MSA) (mm^2)
Measured: During procedure
Acute recoil (percent)
assessed on coronary angiography
Measured: During procedure
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).
Measured: During procedure
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
Measured: During procedure
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
Measured: During procedure
Post OCT stent result optimalization (percent)
composite of additional post-dilation and/or stent placements after OCT
Measured: During procedure
MACE
a composite of time- to-first event rate of cardiac death, target vessel MI, ischemia-driven target vessel revascularization (TVR)
Measured: 1-,3- and 5-year follow-up
Target Lesion Failure (TLF)
defined as cardiac death, target vessel- myocardial infarction and clinically indicated target lesion revascularization)
Measured: 1-,3- and 5-year follow-up
Target Vessel Failure (TVF)
defined as cardiac death, target vessel- myocardial infarction and clinically indicated target vessel revascularization
Measured: 1-,3- and 5-year follow-up
All cause mortality
Measured: 1-,3- and 5-year follow-up
Stent Thrombosis
definite or probable; Academic Research Consortium (ARC) definition
Measured: 1-,3- and 5-year follow-up
Cost-effectiveness analysis
total number of stent, balloons, wires and repeat hospitalizations due to MACE
Measured: 1-,3- and 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Sep 2022
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- single-center, prospective, single blinded randomized clinical trial
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Albert Schweitzer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rohit M. Oemrawsingh, Albert Schweitzer Hospital
- Investigators
- Rohit Oemrawsingh, MD, PhD, Principal investigator, Albert Schweitzer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05292651
- Sponsor's protocol ID
- PERFECT 001
- Acronym
- PERFECTPSP
- Status last verified
- Jan 2024
- First submitted
- 2 Dec 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPtimal stEnt Deployment stRategy oF Contemporary sTents
- ClinicalTrials.gov ID
- NCT05292651
- Acronym / sponsor ID
- PERFECTPSP / PERFECT 001
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Albert Schweitzer HospitalUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- single-center, prospective, single blinded randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| PSP technique | Experimental | Procedure: PCIThe 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. |
| Direct Stenting | Active comparator | Procedure: PCI• 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) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCIpercutaneous coronary intervention | Procedure or surgery | Direct Stenting, PSP technique |
Primary outcome
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
Time frame: During procedure
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
12 secondary outcomes
Minimal stent area (MSA) (mm^2)
Time frame: During procedure
Acute recoil (percent)
Time frame: During procedure
Stent malapposition (percent)
Time frame: During procedure
Mean stent expansion (percent):
Time frame: During procedure
Intra-stent plaque protrusion and thrombus
Time frame: During procedure
Post OCT stent result optimalization (percent)
Time frame: During procedure
MACE
Time frame: 1-,3- and 5-year follow-up
Target Lesion Failure (TLF)
Time frame: 1-,3- and 5-year follow-up
Target Vessel Failure (TVF)
Time frame: 1-,3- and 5-year follow-up
All cause mortality
Time frame: 1-,3- and 5-year follow-up
Stent Thrombosis
Time frame: 1-,3- and 5-year follow-up
Cost-effectiveness analysis
Time frame: 1-,3- and 5-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rohit Oemrawsingh, MD, PhD principal investigator
Albert Schweitzer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PCI in people with Coronary Artery Disease, run by Albert Schweitzer Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Selina Vlieger, MSc (0786541492, s.vlieger@asz.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: During procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.