Coronary CalcificationNCT07277114
DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR
A study testing rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA) and Intravascular Lithotripsy (IVL) in people with Coronary Calcification, run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if the short and long term effect of drug coated balloon (DCB) is non-inferior to drug eluting stent (DES) in patients with severe coronary calcification after optimal calcium modification assessed by quantitative flow ratio (QFR). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Calcification
- What is being tested?
- rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA) and Intravascular Lithotripsy (IVL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 656 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 31 Dec 2030
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Moderate to severe calcified lesions assessed by coronary angiography
- In situ coronary artery calcification
- Target lesion with indications for coronary intervention
- Target lesion vessel diameter ≥ 2.25 mm and ≤ 4.0 mm
- Calcification modification treatment performed using rotational atherectomy, intravascular lithotripsy (IVL), or excimer laser coronary angioplasty (ELCA).
- QFR > 0.8 after calcification modification
Who cannot join
- Patients with ST-segment elevation myocardial infarction:
- Patients with renal failure requiring dialysis or currently undergoing dialysis.
- Patients whose coronary angiography quality is unsuitable for QFR analysis.
- Patients with in-stent restenosis.
- ⑤ Patients with other medical conditions and a life expectancy of <1 year.
- ⑥ Patients scheduled for surgery within 6 months post-procedure, and whose surgery would interfere with continued use of antiplatelet therapy.
Show all 10Show fewer
- ⑦ Patients who cannot tolerate dual antiplatelet therapy.
- ⑧ Patients who cannot adhere to the protocol-required follow-up, or whose participation in the trial is deemed risky by the investigator.
- ⑨ Patients who cannot provide written informed consent or cannot follow the trial protocol.
- ⑩ Patients currently participating in another clinical trial for coronary interventional devices.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, 200032
Jianying Ma, +8602164041990 ext. 5112, ma.jianying@zs-hospital.sh.cn
Qing Qin, +862164041990 ext. 5120, qin.qing@zs-hospital.sh.cn
About this study
Official title: Drug Coated Balloons Versus Drug-Eluting Stents for Severe Coronary Calcification After Optimal Calcium Modification Assessed by QFR (PRECISE CAL Study)
The goal of this clinical trial is to learn if the short and long term effect of drug coated balloon (DCB) is non-inferior to drug eluting stent (DES) in patients with severe coronary calcification after optimal calcium modification assessed by quantitative flow ratio (QFR). The main questions it aims to answer are:
- Researchers will compare to see if DCB is non-inferior to DES when evaluated by major cardiovascular adverse events (MACE) one year after percutaneous coronary intervention (PCI).
- Researchers will compare to see if the perioperative cardiovascular events is different between DCB and DES treated lesions.
- Researchers will compare to see if the QFR is different between DCB and DES treated lesions one year after PCI.
Participants with severe coronary calcification diagnosed by coronary angiography or intravascular ultrasound (IVUS) will receive calcium modification through rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), or intravascular lithotripsy (IVL). Then, QFR will be measured based on angiographic image. QFR >0.8 will be defined as optimal calcium modification and patients will be randomized 1:1 to DCB or DES treated groups. Telephone follow-ups will be conducted at 1 month, 6 months after PCI and .angiophraphy follow-up will be performed at 12 months after PCI.
Read the detailed description
Perioperative cardiovascular events include side branch loss, coronary perforation, no-reflow/slow flow, and perioperative myocardial infarction defined as an elevation of cardiac markers (cTN or CK-MB) greater than 5 times the upper limit of normal.
Definite or probable thrombosis in DCB or DES treated vessels will be documented.
After randomization, if a dissection with restricted blood flow occurs after DCB treatment, DES will be implanted.
- Conditions
- Coronary Calcification
- Being tested
- rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), Intravascular Lithotripsy (IVL)
- Keywords
- coronary calcification, Drug coated balloon, quantitative flow reserve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rotational atherectomy (RA)Device
Rotational atherectomy (RA) is a procedure that uses a diamond-coated, high-speed rotating burr to shave and remove calcified plaque from coronary arteries
excimer laser coronary angioplasty (ELCA)Device
Excimer laser coronary angioplasty (ELCA) is a minimally invasive procedure that uses pulses of ultraviolet light to vaporize plaque in a blocked coronary artery. The procedure involves inserting a catheter with a laser fiber optic tip into an artery in the groin or arm, guiding it to the blockage using X-ray guidance, and then using the laser to ablate the plaque and improve blood flow.
Intravascular Lithotripsy (IVL)Device
An IVL catheter with emitters is inserted into the artery, and it delivers pulsatile shock waves to crack the calcium, which then allows for a balloon or stent to be safely expanded to restore blood flow.
| Study group | Role | What they receive |
|---|---|---|
| Drug coated balloon | Experimental | Drug coated balloon treatment after optimal calcium modification assessed by QFR Receives: Device: rotational atherectomy (RA); Device: excimer laser coronary angioplasty (ELCA); Device: Intravascular Lithotripsy (IVL) |
| Drug eluting stent | Active comparator | Drug eluting stent treatment after optimal calcium modification assessed by QFR Receives: Device: rotational atherectomy (RA); Device: excimer laser coronary angioplasty (ELCA); Device: Intravascular Lithotripsy (IVL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with MACE as defined by cardiovascular death, target lesion revascularization, non-fatal stroke, target vessel non-fatal myocardial infarction.
Measured: One year after treatement.
Secondary outcomes (2)
Perioperative cardiovascular events include side branch loss, coronary perforation, no-reflow/slow flow, and perioperative myocardial infarction defined as an elevation of cardiac markers (cTN or CK-MB) greater than 5 times the upper limit of normal.
Measured: From treatment to hospital discharge
QFR at one year post PCI
Measured: one year after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study start1 Feb 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary CalcificationStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Masking
- None (open label)
- Enrolment
- 656 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Second Affiliated Hospital of Wenzhou Medical University, Tenth People's Hospital affiliated to Tongji University
- Responsible party
- Principal investigator, Junbo Ge, Shanghai Zhongshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277114
- Sponsor's protocol ID
- KY2025283
- Status last verified
- Feb 2026
- First submitted
- 30 Nov 2025
- Last updated
- 2 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Joh HS, Kwon W, Shin D, Lee SH, Hong YJ, Hong D, Lee SY, Park H, Kim S, Lee SY, Koh JS, Kim H, Kim CJ, Choo EH, Yoon HJ, Park SD, Jeon KH, Bae JW, Ahn SG, Kim SE, Choi KH, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention. JACC Asia. 2024 Jun 18;4(7):519-531. doi: 10.1016/j.jacasi.2024.04.007. eCollection 2024 Jul.
PubMed 39101114Muramatsu T, Kozuma K, Tanabe K, Morino Y, Ako J, Nakamura S, Yamaji K, Kohsaka S, Amano T, Kobayashi Y, Ikari Y, Kadota K, Nakamura M; Task Force of the Japanese Association of Cardiovascular Intervention, Therapeutics (CVIT). Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2023 Apr;38(2):166-176. doi: 10.1007/s12928-023-00921-2. Epub 2023 Feb 27.
PubMed 36847902Shin ES, Bang LH, Jun EJ, Her AY, Chung JH, Garg S, Lee JM, Doh JH, Nam CW, Koo BK, Tang Q. Provisional drug-coated balloon treatment guided by physiology on de novo coronary lesion. Cardiol J. 2021;28(4):615-622. doi: 10.5603/CJ.a2020.0105. Epub 2020 Aug 13.
PubMed 32789835Guedeney P, Claessen BE, Mehran R, Mintz GS, Liu M, Sorrentino S, Giustino G, Farhan S, Leon MB, Serruys PW, Smits PC, von Birgelen C, Ali ZA, Genereux P, Redfors B, Madhavan MV, Ben-Yehuda O, Stone GW. Coronary Calcification and Long-Term Outcomes According to Drug-Eluting Stent Generation. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1417-1428. doi: 10.1016/j.jcin.2020.03.053.
PubMed 32553329
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug Coated Balloons Versus Drug-Eluting Stents for Severe Coronary Calcification After Optimal Calcium Modification Assessed by QFR (PRECISE CAL Study)
- ClinicalTrials.gov ID
- NCT07277114
- Acronym / sponsor ID
- KY2025283
- Conditions
- Coronary Calcification
- Keywords
- coronary calcification, Drug coated balloon, quantitative flow reserve
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 656 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine, Second Affiliated Hospital of Wenzhou Medical University, Tenth People's Hospital affiliated to Tongji University
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 11 Dec 2025 (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 clinical trial is to learn if the short and long term effect of drug coated balloon (DCB) is non-inferior to drug eluting stent (DES) in patients with severe coronary calcification after optimal calcium modification assessed by quantitative flow ratio (QFR). The main questions it aims to answer are:
- Researchers will compare to see if DCB is non-inferior to DES when evaluated by major cardiovascular adverse events (MACE) one year after percutaneous coronary intervention (PCI).
- Researchers will compare to see if the perioperative cardiovascular events is different between DCB and DES treated lesions.
- Researchers will compare to see if the QFR is different between DCB and DES treated lesions one year after PCI.
Participants with severe coronary calcification diagnosed by coronary angiography or intravascular ultrasound (IVUS) will receive calcium modification through rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), or intravascular lithotripsy (IVL). Then, QFR will be measured based on angiographic image. QFR >0.8 will be defined as optimal calcium modification and patients will be randomized 1:1 to DCB or DES treated groups. Telephone follow-ups will be conducted at 1 month, 6 months after PCI and .angiophraphy follow-up will be performed at 12 months after PCI.
Detailed description
Perioperative cardiovascular events include side branch loss, coronary perforation, no-reflow/slow flow, and perioperative myocardial infarction defined as an elevation of cardiac markers (cTN or CK-MB) greater than 5 times the upper limit of normal.
Definite or probable thrombosis in DCB or DES treated vessels will be documented.
After randomization, if a dissection with restricted blood flow occurs after DCB treatment, DES will be implanted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug coated balloon | Experimental | Device: rotational atherectomy (RA), Device: excimer laser coronary angioplasty (ELCA), Device: Intravascular Lithotripsy (IVL)Drug coated balloon treatment after optimal calcium modification assessed by QFR |
| Drug eluting stent | Active comparator | Device: rotational atherectomy (RA), Device: excimer laser coronary angioplasty (ELCA), Device: Intravascular Lithotripsy (IVL)Drug eluting stent treatment after optimal calcium modification assessed by QFR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥ 18 years
Key exclusion criteria (10 listed)
- Patients with ST-segment elevation myocardial infarction:
- ⑤ Patients with other medical conditions and a life expectancy of <1 year.
- ⑥ Patients scheduled for surgery within 6 months post-procedure, and whose surgery would interfere with continued use of antiplatelet therapy.
- ⑦ Patients who cannot tolerate dual antiplatelet therapy.
- ⑧ Patients who cannot adhere to the protocol-required follow-up, or whose participation in the trial is deemed risky by the investigator.
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 |
|---|---|---|
| rotational atherectomy (RA)Rotational atherectomy (RA) is a procedure that uses a diamond-coated, high-speed rotating burr to shave and remove calcified plaque from coronary arteries | Device | Drug coated balloon, Drug eluting stent |
| excimer laser coronary angioplasty (ELCA)Excimer laser coronary angioplasty (ELCA) is a minimally invasive procedure that uses pulses of ultraviolet light to vaporize plaque in a blocked coronary artery. The procedure involves inserting a catheter with a laser fiber optic tip into an artery in the groin or arm, guiding it to the blockage using X-ray guidance, and then using the laser to ablate the plaque and improve blood flow. | Device | Drug coated balloon, Drug eluting stent |
| Intravascular Lithotripsy (IVL)An IVL catheter with emitters is inserted into the artery, and it delivers pulsatile shock waves to crack the calcium, which then allows for a balloon or stent to be safely expanded to restore blood flow. | Device | Drug coated balloon, Drug eluting stent |
Primary outcome
Number of participants with MACE as defined by cardiovascular death, target lesion revascularization, non-fatal stroke, target vessel non-fatal myocardial infarction.
Time frame: One year after treatement.
2 secondary outcomes
Perioperative cardiovascular events include side branch loss, coronary perforation, no-reflow/slow flow, and perioperative myocardial infarction defined as an elevation of cardiac markers (cTN or CK-MB) greater than 5 times the upper limit of normal.
Time frame: From treatment to hospital discharge
QFR at one year post PCI
Time frame: one year after treatment
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 2 Mar 2026.
- Results publication: PubMed 39101114Joh HS, Kwon W, Shin D, Lee SH, Hong YJ, Hong D, Lee SY, Park H, Kim S, Lee SY, Koh JS, Kim H, Kim CJ, Choo EH, Yoon HJ, Park SD, Jeon KH, Bae JW, Ahn SG, Kim SE, Choi KH, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee JM. Drug-Coated Balloon Angioplasty in Patients Undergoing Complex Percutaneous Coronary Intervention. JACC Asia. 2024 Jun 18;4(7):519-531. doi: 10.1016/j.jacasi.2024.04.007. eCollection 2024 Jul.
- Results publication: PubMed 36847902Muramatsu T, Kozuma K, Tanabe K, Morino Y, Ako J, Nakamura S, Yamaji K, Kohsaka S, Amano T, Kobayashi Y, Ikari Y, Kadota K, Nakamura M; Task Force of the Japanese Association of Cardiovascular Intervention, Therapeutics (CVIT). Clinical expert consensus document on drug-coated balloon for coronary artery disease from the Japanese Association of Cardiovascular Intervention and Therapeutics. Cardiovasc Interv Ther. 2023 Apr;38(2):166-176. doi: 10.1007/s12928-023-00921-2. Epub 2023 Feb 27.
- Results publication: PubMed 32789835Shin ES, Bang LH, Jun EJ, Her AY, Chung JH, Garg S, Lee JM, Doh JH, Nam CW, Koo BK, Tang Q. Provisional drug-coated balloon treatment guided by physiology on de novo coronary lesion. Cardiol J. 2021;28(4):615-622. doi: 10.5603/CJ.a2020.0105. Epub 2020 Aug 13.
- Results publication: PubMed 32553329Guedeney P, Claessen BE, Mehran R, Mintz GS, Liu M, Sorrentino S, Giustino G, Farhan S, Leon MB, Serruys PW, Smits PC, von Birgelen C, Ali ZA, Genereux P, Redfors B, Madhavan MV, Ben-Yehuda O, Stone GW. Coronary Calcification and Long-Term Outcomes According to Drug-Eluting Stent Generation. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1417-1428. doi: 10.1016/j.jcin.2020.03.053.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA) and Intravascular Lithotripsy (IVL) in people with Coronary Calcification, run by Shanghai Zhongshan 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 7 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 2 Mar 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?
Contact Jianying Ma (+86-64041990-5115, ma.jianying@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with MACE as defined by cardiovascular death, target lesion revascularization, non-fatal stroke, target vessel non-fatal myocardial infarction. (time frame: One year after treatement.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07277114, which also lists 4 linked publications.
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 Mar 2026.