Coronary Artery CalcificationNCT07699965
Prognostic Impact of Coronary Microvascular Dysfunction After IVL Versus RA in Patients With Severe Coronary Calcification Undergoing PCI
An observational study of Coronary Artery Calcification and Intravascular Lithotripsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this observational study is to lean that whether the distinct mechanisms by which intravascular lithotripsy (IVL) and rotational atherectomy (RA) treat severe coronary calcification differentially affect the microcirculation, leading to coronary microvascular dysfunction (CMD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Calcification, Intravascular Lithotripsy, Coronary Microcirculation Dysfunction
- How many people
- 590 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2018to 30 Sep 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive patients who underwent RA or IVL due to serve calcification during the PCI between January 1, 2018, and October 31, 2024.
Who may be able to join
- Consecutive patients who underwent RA or IVL due to serve calcification during the PCI. Severe calcification was defined angiographically as radiopacities visible on both sides of the vessel lumen before contrast injection, or by intravascular ultrasound (IVUS) as a circumferential arc of calcification ≥270° extending for ≥5 mm in length-
Who cannot join
- encompassed the presence of severe calcification treated with RA and IVL, in-stent restenosis and suboptimal angiographic image quality
Trial locations and contacts
1 site in 1 country.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine 88 Jiefang Road
Hangzhou, Zhejiang, 310009
About this study
Official title: A Study Comparing the Effects of Coronary Rotational Atherectomy and Intravascular Lithotripsy on Coronary Microcirculation in Patients With Severe Calcified Lesions
The goal of this observational study is to lean that whether the distinct mechanisms by which intravascular lithotripsy (IVL) and rotational atherectomy (RA) treat severe coronary calcification differentially affect the microcirculation, leading to coronary microvascular dysfunction (CMD).
The main question it aims to answer is: we evaluated the prognostic value of post-percutaneous coronary intervention (PCI) CMD, assessed by the angiography-derived index of microcirculatory resistance (angio-IMR), in patients with severe coronary calcification undergoing RA or IVL.
Participants will answer survey questions about their clinical outcomes for 1 year by telephone
Read the detailed description
This retrospective, multicenter, observational study.The study protocol was approved by the institutional review board at participating centers and was conducted in accordance with the principles of the Declaration of Helsinki. Owing to the retrospective nature of the study, the requirement for written informed consent was waived.Consecutive patients who underwent RA or IVL due to serve calcification during the PCI at the three participating centers between January 1, 2018, and October 31, 2024, were included in this retrospective analysis. Severe calcification was defined angiographically as radiopacities visible on both sides of the vessel lumen before contrast injection, or by intravascular ultrasound (IVUS) as a circumferential arc of calcification ≥270° extending for ≥5 mm in length. Exclusion criteria encompassed the presence of severe calcification treated with RA and IVL, in-stent restenosis and suboptimal angiographic image quality.The follow-up entailed the utilization of a multipronged approach, encompassing clinic visits, medical record reviews and telephone contacts.
- Conditions
- Coronary Artery Calcification, Intravascular Lithotripsy, Coronary Microcirculation Dysfunction
- Keywords
- Intravascular lithotripsy, Rotational atherectomy, Coronary microcirculation dysfunction, Coronary artery calcification, Index of microcirculatory resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Intravascular lithotripsy group | Angio-IMR>=25 OR Angio-IMR<25 | |
| Rotational atherectomy | Angio-IMR>=25 OR Angio-IMR <25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
composite of cardiac death, myocardial infarction, target vessel revascularization, or readmission for unstable angina
Measured: 1 year
Secondary outcomes (1)
target vessel failure
composite of cardiac death, myocardial infarction, or target-vessel revascularization
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start1 Jan 2018
- Primary completion31 Dec 2024
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery CalcificationStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 590 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699965
- Sponsor's protocol ID
- 20251689
- Status last verified
- Jun 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study Comparing the Effects of Coronary Rotational Atherectomy and Intravascular Lithotripsy on Coronary Microcirculation in Patients With Severe Calcified Lesions
- ClinicalTrials.gov ID
- NCT07699965
- Acronym / sponsor ID
- 20251689
- Conditions
- Coronary Artery Calcification, Intravascular Lithotripsy, Coronary Microcirculation Dysfunction
- Keywords
- Intravascular lithotripsy, Rotational atherectomy, Coronary microcirculation dysfunction, Coronary artery calcification, Index of microcirculatory resistance
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 590 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Jul 2026 (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 goal of this observational study is to lean that whether the distinct mechanisms by which intravascular lithotripsy (IVL) and rotational atherectomy (RA) treat severe coronary calcification differentially affect the microcirculation, leading to coronary microvascular dysfunction (CMD).
The main question it aims to answer is: we evaluated the prognostic value of post-percutaneous coronary intervention (PCI) CMD, assessed by the angiography-derived index of microcirculatory resistance (angio-IMR), in patients with severe coronary calcification undergoing RA or IVL.
Participants will answer survey questions about their clinical outcomes for 1 year by telephone
Detailed description
This retrospective, multicenter, observational study.The study protocol was approved by the institutional review board at participating centers and was conducted in accordance with the principles of the Declaration of Helsinki. Owing to the retrospective nature of the study, the requirement for written informed consent was waived.Consecutive patients who underwent RA or IVL due to serve calcification during the PCI at the three participating centers between January 1, 2018, and October 31, 2024, were included in this retrospective analysis. Severe calcification was defined angiographically as radiopacities visible on both sides of the vessel lumen before contrast injection, or by intravascular ultrasound (IVUS) as a circumferential arc of calcification ≥270° extending for ≥5 mm in length. Exclusion criteria encompassed the presence of severe calcification treated with RA and IVL, in-stent restenosis and suboptimal angiographic image quality.The follow-up entailed the utilization of a multipronged approach, encompassing clinic visits, medical record reviews and telephone contacts.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravascular lithotripsy group | – | –Angio-IMR>=25 OR Angio-IMR<25 |
| Rotational atherectomy | – | –Angio-IMR>=25 OR Angio-IMR <25 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients who underwent RA or IVL due to serve calcification during the PCI between January 1, 2018, and October 31, 2024.
Key inclusion criteria (1 listed)
- Consecutive patients who underwent RA or IVL due to serve calcification during the PCI. Severe calcification was defined angiographically as radiopacities visible on both sides of the vessel lumen before contrast injection, or by intravascular ultrasound (IVUS) as a circumferential arc of calcification ≥270° extending for ≥5 mm in length-
Key exclusion criteria (1 listed)
- encompassed the presence of severe calcification treated with RA and IVL, in-stent restenosis and suboptimal angiographic image quality
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MACE
Time frame: 1 year
composite of cardiac death, myocardial infarction, target vessel revascularization, or readmission for unstable angina
1 secondary outcome
target vessel failure
Time frame: 1 year
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Coronary Artery Calcification
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 2
REducing Systemic Inflammation With LOw-dose Colchicine to ImproVE Cardiovascular Calcification in Chronic Kidney Disease: A Pilot Randomized Open-Label Trial
Chronic Kidney Disease Mineral and Bone Disorder, Cognitive Function
Not yet recruitingObservational study
Relationship Between Insulin Dose and Complications in Type 1 Diabetes
Diabetes Mellitus, Type 1 Diabetes, Cardiovascular Diseases (CVD)
Recruiting
AVS Pulse Intravascular Lithotripsy™ (Pulse IVL™) to Open Vessels With Calcific Walls and Enhance Vascular Compliance and Remodeling for Coronary Artery Disease
Coronary Arterial Disease (CAD)
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Calcification and Intravascular Lithotripsy, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 1 year). 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 13 Jul 2026.