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

February 26, 2026 updated by: Junbo Ge, Shanghai Zhongshan Hospital

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:

  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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

656

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Drug coated balloon
Drug coated balloon treatment after optimal calcium modification assessed by QFR
Device: 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: 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: 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.
Active Comparator: Drug eluting stent
Drug eluting stent treatment after optimal calcium modification assessed by QFR
Device: 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: 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
One year after treatement.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
From treatment to hospital discharge
QFR at one year post PCI
Time Frame: one year after treatment
one year after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Zhongshan Hospital

Collaborators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2030

Study Registration Dates

First Submitted

November 30, 2025

First Submitted That Met QC Criteria

November 30, 2025

First Posted (Actual)

December 11, 2025

Study Record Updates

Last Update Posted (Actual)

March 2, 2026

Last Update Submitted That Met QC Criteria

February 26, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY2025283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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