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NCT Number: NCT07277114

DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR

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:

1. 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). 2. Researchers will compare to see if the perioperative cardiovascular events is different between DCB and DES treated lesions. 3. 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.

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Key information

Conditions

Coronary Calcification

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. QFR at one year post PCI

    Time frame: one year after treatment

Study contacts

Contact information is provided by the study sponsor or research team.

Jianying Ma

CONTACT

[email protected]

+86-64041990-5115

Sponsors and collaborators

Lead sponsor

Shanghai Zhongshan Hospital

Other

Collaborators

  • Second Affiliated Hospital of Wenzhou Medical University
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
  • Tenth People's Hospital affiliated to Tongji University

Registry information

Official study title

Drug Coated Balloons Versus Drug-Eluting Stents for Severe Coronary Calcification After Optimal Calcium Modification Assessed by QFR (PRECISE CAL Study)

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Dec 11, 2025
Registry last updated
Mar 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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