Coronary Artery DiseaseNCT06669195
Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions
A study testing Intravascular lithotripsy group and high-pressure balloon group in people with Coronary Artery Disease and Calcification, run by Xuzhou Third People's Hospital.
Trial summary
Percutaneous coronary intervention (PCI) is the standard treatment for patients with coronary artery disease who have an indication for surgery. Coronary artery calcification not only makes stent delivery and expansion more difficult during PCI, but also increases the risk of vessel perforation. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Disease, Calcification
- What is being tested?
- Intravascular lithotripsy group and high-pressure balloon group
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 12 Dec 2024to 13 Mar 2027
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Radiography inclusion criteria
- the angiography identified a severely calcified lesion with acute stent under-expansion, i.e., residual stenosis >20% after stenting and 16-atm dilatation with a post-dilatation balloon;
- target lesion stenosis must be ≥70% or ≥50% with clear evidence of myocardial ischaemia (visual assessment);
- target lesion vessel diameter is between 2.75mm and 4.0mm, target lesion length must be ≤30 mm (visual assessment);
- General inclusion criteria
- subjects at the age between ≥18 and ≤80 years old;
- patients with symptoms or evidence of myocardial ischaemia;
- subjects are willing to participate in the study, sign informed consent form, and accept clinical and angiography follow-up after PCI.
Who cannot join
- Radiography exclusion criteria
- in-stent lesions;
- For the left main disease and bifurcation lesion (branch vessel diameter shall be ≥ 2.5mm);
- Target lesions were total occlusive lesions (acute or chronic), long lesions (>30 mm), lesion vessel reference diameters >4.0 mm, and lesion angiomatous dilatation;
- General inclusion criteria
- Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 35%;
Show all 13Show fewer
- Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
- Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
- Patients with severe renal failure(eGFR<30ml/minute) or such medical history, failure to comply with angiography conditions;
- Subjects who are intolerance or allergic to heparin, contrast agent, Biolimus, polyethylene oxide and polylactic acid - glycolic acid polymer;
- Patients who plans to accept selective operation within 1 year;
- Patients who are participating in the clinical trial of other drug or device without reaching the time limit of primary endpoint;
- Subjects who are considered to be not applicable to be enrolled by investigators due to other reasons.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility and Safety of Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions
Percutaneous coronary intervention (PCI) is the standard treatment for patients with coronary artery disease who have an indication for surgery. Coronary artery calcification not only makes stent delivery and expansion more difficult during PCI, but also increases the risk of vessel perforation. In addition, calcified plaque can lead to incomplete stent expansion, which increases the risk of in-stent restenosis and thrombosis. Although the technology and techniques of interventional devices continue to improve, heavily calcified lesions remain an important risk factor for PCI failure.
This study is a prospective, multicenter, randomized study. It is planned to select 40 cases of subjects with calcified plaque can lead to incomplete stent expansion who meet the inclusion/exclusion criteria. They are randomly dividing them into Intravascular lithotripsy treatment group and high-pressure balloon treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, and 12 months after operation. Follow-up with angiography and OCT are conducted at 12 months. The primary endpoint was thickness of neointima at 12 months.
- Conditions
- Coronary Artery Disease, Calcification
- Being tested
- Intravascular lithotripsy group, high-pressure balloon group
- Keywords
- Intravascular lithotripsy, stent under-expansion, calcified coronary lesions
- Medical subject headings
- Coronary Artery Disease, Calcinosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular lithotripsy groupDevice
20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of Intravascular lithotripsy group.
high-pressure balloon groupDevice
20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of high-pressure balloon group.
| Study group | Role | What they receive |
|---|---|---|
| Intravascular lithotripsy group | Experimental | Not described Receives: Device: Intravascular lithotripsy group |
| high-pressure balloon group | Active comparator | Not described Receives: Device: high-pressure balloon group |
What is being measured
The primary outcome is the main question the study is designed to answer.
the thickness of neointima
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start12 Dec 2024 (estimated)
- Primary completion13 Dec 2026 (estimated)
- Study completion13 Mar 2027 (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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuzhou Third People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06669195
- Sponsor's protocol ID
- 2024-02-007-H01
- Status last verified
- Oct 2024
- First submitted
- 31 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions
- ClinicalTrials.gov ID
- NCT06669195
- Acronym / sponsor ID
- 2024-02-007-H01
- Conditions
- Coronary Artery Disease, Calcification
- Keywords
- Intravascular lithotripsy, stent under-expansion, calcified coronary lesions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Xuzhou Third People's HospitalUniversity, hospital or other
- Study start
- 12 Dec 2024 (estimated)
- Primary completion
- 13 Dec 2026 (estimated)
- Study completion
- 13 Mar 2027 (estimated)
- First posted
- 1 Nov 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) is the standard treatment for patients with coronary artery disease who have an indication for surgery. Coronary artery calcification not only makes stent delivery and expansion more difficult during PCI, but also increases the risk of vessel perforation. In addition, calcified plaque can lead to incomplete stent expansion, which increases the risk of in-stent restenosis and thrombosis. Although the technology and techniques of interventional devices continue to improve, heavily calcified lesions remain an important risk factor for PCI failure.
This study is a prospective, multicenter, randomized study. It is planned to select 40 cases of subjects with calcified plaque can lead to incomplete stent expansion who meet the inclusion/exclusion criteria. They are randomly dividing them into Intravascular lithotripsy treatment group and high-pressure balloon treatment group according to the ratio of 1:1. All subjects accept clinical follow-up after operation, at 30 days, 6 months, and 12 months after operation. Follow-up with angiography and OCT are conducted at 12 months. The primary endpoint was thickness of neointima at 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravascular lithotripsy group | Experimental | Device: Intravascular lithotripsy group |
| high-pressure balloon group | Active comparator | Device: high-pressure balloon group |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Radiography inclusion criteria
- General inclusion criteria
- subjects at the age between ≥18 and ≤80 years old;
- patients with symptoms or evidence of myocardial ischaemia;
- subjects are willing to participate in the study, sign informed consent form, and accept clinical and angiography follow-up after PCI.
Key exclusion criteria (13 listed)
- Radiography exclusion criteria
- General inclusion criteria
- Patients with severe congestive heart failure (NYHA Level IV severe heart failure) or severe valvular heart disease; or left ventricular ejection fraction of less than 35%;
- Patients with stroke, peptic ulcer or gastrointestinal bleeding within the past 6 months; or patients with bleeding tendency or coagulation disorders;
- Patients with severe liver failure (ALT and AST are larger than 3 times of the upper limit of normal value), who are judged to be not applicable to angiography by investigators;
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 lithotripsy group20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of Intravascular lithotripsy group. | Device | Intravascular lithotripsy group |
| high-pressure balloon group20 subjects with stent under-expansion in calcified coronary lesions who met the inclusion/exclusion criteria were enrolled; subjects were assigned to the treatment group of high-pressure balloon group. | Device | high-pressure balloon group |
Primary outcome
the thickness of neointima
Time frame: 12 months
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 Nov 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Disease
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
RecruitingObservational study
Preoperative Gastric Ultrasound and Left Ventricular Function in Coronary Artery Bypass Surgery
Coronary Artery Disease, Left Ventricular Systolic Dysfunction
Active, not recruiting
The OCTOBER Trial - European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction (OCTOBER)
Ischaemic Heart Disease, Ischemic Heart Disease
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.
Questions about this trial
What is this clinical trial studying?
A study testing Intravascular lithotripsy group and high-pressure balloon group in people with Coronary Artery Disease and Calcification, run by Xuzhou Third People's Hospital.
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 8 inclusion and 13 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: opening soon, as of the sponsor's last update on 1 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 yaojun zhang, Ph.D. (0516-85786383, mts0207@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the thickness of neointima (time frame: 12 months). 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 Nov 2024.