Severely Calcified Coronary StenosesREC-CHIPCACNCT06238518
Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions
A study testing Intravascular Lithotripsy and Conventional lesion preparation strategy in people with Severely Calcified Coronary Stenoses and De Novo Stenosis, run by Xijing Hospital at 1 site in China.
Trial summary
Percutaneous coronary intervention (PCI) encounters challenges with calcified coronary lesions, leading to potential issues such as failed balloon dilatation, incomplete stent expansion, and increased risks of adverse events post-PCI, including stent restenosis and thrombosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severely Calcified Coronary Stenoses, De Novo Stenosis
- What is being tested?
- Intravascular Lithotripsy and Conventional lesion preparation strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- 5 Jan 2024to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- General Inclusion Criteria:
- Patients with acute or chronic coronary artery syndrome indicated for PCI with stenting.
- Able to understand and provide informed consent and comply with all study procedures
- Angiographic Inclusion Criteria:
- Native and de novo coronary artery disease
- Lesion navigable by a 0.014" guidewire.
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- Target lesion is severely calcified, meeting one of the following criteria:
- Presence of calcium ≥ 270°, lengths ≥ 5mm, and thickness ≥ 0.5mm at one cross-section as assessed by OCT
- If the OCT catheter is unable to pass through the target lesion after dilatation due to calcification or tortuosity, and the target lesion is severely calcified on both sides of the arterial wall during angiography, with the length of the calcification >15 mm, the lesion will be recognized as a severely calcified lesion, meeting the criteria for enrollment
Who cannot join
- General Exclusion Criteria:
- Patients under 18 years of age.
- Incapable of providing informed consent.
- Female patients who are pregnant or nursing (a pregnancy test must be conducted within 7 days before the index procedure for women of childbearing potential, as per local practice).
- Concurrent medical conditions with a life expectancy of less than 1 year.
- Hemodynamic instability.
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- Known contraindications to medications such as Heparin, anticoagulation, antiplatelet drugs, or contrast.
- Active bleeding.
- New-onset stroke or transient ischemic attack (TIA) within 90 days prior to enrollment.
- Severe renal dysfunction (eGFR ≤ 30 ml/min).
- Patients scheduled to undergo cardiac intervention or cardiac surgery within 30 days of the index procedure.
- Recent ST-segment elevation myocardial infarction (STEMI) within 7 days or recent cardiogenic shock.
- Lesions located in surgical conduits.
- Angiographic Exclusion Criteria:
- Target vessel exhibiting C-F type dissection.
- Thrombosis observed by angiography or OCT.
- Presence of an aneurysm within 10 mm of the target lesion.
- Left main ostial lesion
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ling Tao
Xi'an, Shannxi, 710032
Chao Gao, woshigaochao@gmail.com
About this study
Official title: Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions: an Investigator-initiated, Open-label, Multicentre, Randomised, Superiority Trial
Percutaneous coronary intervention (PCI) encounters challenges with calcified coronary lesions, leading to potential issues such as failed balloon dilatation, incomplete stent expansion, and increased risks of adverse events post-PCI, including stent restenosis and thrombosis.
Intravascular lithotripsy (IVL), a novel approach for severely calcified coronary lesion preparation, has shown promising preliminary outcomes. Combining IVL with conventional approaches, such as Rotational atherectomy (RA), non-compliant balloons, or cutting balloons, may associated with additional benefit than conventional approaches only in terms of better stent expansion and lower long-term adverse events.
This pilot randomized trial aims to investigate whether combining IVL to conventional therapy surpasses the efficacy of conventional approaches alone. The primary effectiveness endpoint is final stent expansion assessed by post-procedure optical coherence tomography (OCT), and the primary safety endpoint is target lesion failure (TVF). The trial seeks to provide valuable insights into the optimal approach for managing severely calcified coronary lesions during PCI.
- Being tested
- Intravascular Lithotripsy, Conventional lesion preparation strategy
- Keywords
- Severely Calcified Coronary Stenoses, Intravascular Lithotripsy, percutaneous coronary intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular LithotripsyProcedure or surgery
The size of the IVL balloon catheter is selected in a 1:1 ratio to the distal reference vessel diameter. The balloon catheter is then inflated to 4 atm, and 10 impulses are delivered. Subsequently, the balloon is inflated to 8 atm and then deflated to re-establish blood flow. Up to 100 impulses can be delivered, and the balloon can be repositioned within the lesion. In cases involving multiple lesions with different reference vessel diameters, various sizes of IVL balloons may be employed. If the IVL balloon catheter is unable to pass through the lesion, pre-dilatation can be performed using a smaller diameter noncompliant balloon or rotational atherectomy.
Conventional lesion preparation strategyProcedure or surgery
Conventional lesion preparation strategy includes the use of Compliant, noncompliant, cutting, or scoring balloons, Excimer laser coronary atherectomy, or Rotational atherectomy at the discretion of the operator.
| Study group | Role | What they receive |
|---|---|---|
| Conventional lesion preparation plus Intravascular Lithotripsy strategy | Experimental | IVL could be performed before, amidst, or after Conventional lesion preparation therapy; However, the use of IVL treatment is mandatory. Receives: Procedure: Intravascular Lithotripsy; Procedure: Conventional lesion preparation strategy |
| Conventional lesion preparation strategy | Active comparator | Conventional lesion preparation strategy includes the use of Compliant, noncompliant, cutting, or scoring balloons, Excimer laser coronary atherectomy, or Rotational atherectomy at the discretion of the operator. Receives: Procedure: Conventional lesion preparation strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Final stent expansion (%) assessed by OCT
The primary efficacy endpoint of the trial is the Final stent expansion %, defined as the minimum stent area (MSA) / mean reference lumen area assessed by OCT.
Measured: Measured by the data collected at the end of the PCI procedure
Target vessel failure (TVF)
The primary safety endpoint of the trial is target vessel failure (TVF), defined as a non-hierarchical composite endpoint of cardiovascular death, target-vessel myocardial infarction (TV-MI), and clinically indicated target vessel revascularization (CI-TVR).
Measured: 1, 12, 36, and 60 months
Secondary outcomes (1)
Major cardiovascular adverse events
Major adverse cardiovascular events (MACE) is defined as a hierarchical composite of cardiovascular death, target-vessel myocardial infarction, clinically indicated target vessel revascularization, stent delivery failure, and suboptimal stent deployment.
The between-group difference in terms of MACE will be compared using the Win Ratio approach in the abovementioned order.
Measured: 1, 12, 36, and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2024
- Study start5 Jan 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severely Calcified Coronary StenosesStudies of the same condition, open and under way.
- More trials run by Xijing HospitalThe sponsor's other registered studies.
- 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
- Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of adding IVL to Conventional Therapy compared to Conventional Therapy only in calcified coronary lesions.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LingTao, Xijing Hospital
- Investigators
- Ling Tao, M.D, Ph.D., Study chair, Xijing HospitalChao Gao, M.D, Ph.D., Study chair, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06238518
- Sponsor's protocol ID
- KY20232390-C-1
- Acronym
- REC-CHIPCAC
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Lithotripsy Versus Conventional Therapy for Severely Calcified Coronary Artery Lesions: an Investigator-initiated, Open-label, Multicentre, Randomised, Superiority Trial
- ClinicalTrials.gov ID
- NCT06238518
- Acronym / sponsor ID
- REC-CHIPCAC / KY20232390-C-1
- Keywords
- Severely Calcified Coronary Stenoses, Intravascular Lithotripsy, percutaneous coronary intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 2 Feb 2024 (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.
Percutaneous coronary intervention (PCI) encounters challenges with calcified coronary lesions, leading to potential issues such as failed balloon dilatation, incomplete stent expansion, and increased risks of adverse events post-PCI, including stent restenosis and thrombosis.
Intravascular lithotripsy (IVL), a novel approach for severely calcified coronary lesion preparation, has shown promising preliminary outcomes. Combining IVL with conventional approaches, such as Rotational atherectomy (RA), non-compliant balloons, or cutting balloons, may associated with additional benefit than conventional approaches only in terms of better stent expansion and lower long-term adverse events.
This pilot randomized trial aims to investigate whether combining IVL to conventional therapy surpasses the efficacy of conventional approaches alone. The primary effectiveness endpoint is final stent expansion assessed by post-procedure optical coherence tomography (OCT), and the primary safety endpoint is target lesion failure (TVF). The trial seeks to provide valuable insights into the optimal approach for managing severely calcified coronary lesions during PCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, 1:1 randomized, controlled, multicenter trial to assess effectiveness and safety of adding IVL to Conventional Therapy compared to Conventional Therapy only in calcified coronary lesions.
| Arm | Type | Receives |
|---|---|---|
| Conventional lesion preparation plus Intravascular Lithotripsy strategy | Experimental | Procedure: Intravascular Lithotripsy, Procedure: Conventional lesion preparation strategyIVL could be performed before, amidst, or after Conventional lesion preparation therapy; However, the use of IVL treatment is mandatory. |
| Conventional lesion preparation strategy | Active comparator | Procedure: Conventional lesion preparation strategyConventional lesion preparation strategy includes the use of Compliant, noncompliant, cutting, or scoring balloons, Excimer laser coronary atherectomy, or Rotational atherectomy at the discretion of the operator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients with acute or chronic coronary artery syndrome indicated for PCI with stenting.
- Able to understand and provide informed consent and comply with all study procedures
- Native and de novo coronary artery disease
- Lesion navigable by a 0.014" guidewire.
- Target lesion is severely calcified, meeting one of the following criteria:
Key exclusion criteria (18 listed)
- Patients under 18 years of age.
- Incapable of providing informed consent.
- Female patients who are pregnant or nursing (a pregnancy test must be conducted within 7 days before the index procedure for women of childbearing potential, as per local practice).
- Concurrent medical conditions with a life expectancy of less than 1 year.
- Hemodynamic instability.
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 |
|---|---|---|
| Intravascular LithotripsyThe size of the IVL balloon catheter is selected in a 1:1 ratio to the distal reference vessel diameter. The balloon catheter is then inflated to 4 atm, and 10 impulses are delivered. Subsequently, the balloon is inflated to 8 atm and then deflated to re-establish blood flow. Up to 100 impulses can be delivered, and the balloon can be repositioned within the lesion. In cases involving multiple lesions with different reference vessel diameters, various sizes of IVL balloons may be employed. If the IVL balloon catheter is unable to pass through the lesion, pre-dilatation can be performed using a smaller diameter noncompliant balloon or rotational atherectomy. | Procedure or surgery | Conventional lesion preparation plus Intravascular Lithotripsy strategy |
| Conventional lesion preparation strategyConventional lesion preparation strategy includes the use of Compliant, noncompliant, cutting, or scoring balloons, Excimer laser coronary atherectomy, or Rotational atherectomy at the discretion of the operator. | Procedure or surgery | Conventional lesion preparation plus Intravascular Lithotripsy strategy, Conventional lesion preparation strategy |
Primary outcome
Final stent expansion (%) assessed by OCT
Time frame: Measured by the data collected at the end of the PCI procedure
The primary efficacy endpoint of the trial is the Final stent expansion %, defined as the minimum stent area (MSA) / mean reference lumen area assessed by OCT.
Target vessel failure (TVF)
Time frame: 1, 12, 36, and 60 months
The primary safety endpoint of the trial is target vessel failure (TVF), defined as a non-hierarchical composite endpoint of cardiovascular death, target-vessel myocardial infarction (TV-MI), and clinically indicated target vessel revascularization (CI-TVR).
1 secondary outcome
Major cardiovascular adverse events
Time frame: 1, 12, 36, and 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
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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. This study is not recruiting at the moment.
Ling Tao, M.D, Ph.D. study chair
Xijing Hospital
Chao Gao, M.D, Ph.D. study chair
Xijing 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 Intravascular Lithotripsy and Conventional lesion preparation strategy in people with Severely Calcified Coronary Stenoses and De Novo Stenosis, run by Xijing Hospital at 1 site in China.
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 9 inclusion and 18 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: status not confirmed, as of the sponsor's last update on 2 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chao Gao,, M.D, Ph.D (+86-18629551066, woshigaochao@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Final stent expansion (%) assessed by OCT (time frame: Measured by the data collected at the end of the PCI procedure). The study lists 2 primary outcomes in all. 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 2 Feb 2024.