Home › Trials › NCT07277114
Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Drug‑coated balloon versus drug‑eluting stent for severely calcified coronary arteries after calcium modification

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

Run by Shanghai Zhongshan Hospital · NCT07277114 · Data updated 2026-11-12

This study tests whether drug‑coated balloons work as well as drug‑eluting stents for adults with severe coronary artery calcification after the artery has been treated to modify the calcium.

More Coronary Artery Calcification trials

Quick facts

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment656 (estimated)
SponsorShanghai Zhongshan Hospital
Academic / other
Locations1 site (Shanghai)
StatusRecruiting
StartedFebruary 1, 2026
Main results expectedDecember 31, 2028
Study endsDecember 31, 2030
Registry record updatedMarch 2, 2026
Trial IDNCT07277114 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults (≥18 years) with moderate to severe coronary artery calcification requiring PCI in a vessel 2.25–4.0 mm who undergo calcium modification (RA, IVL, or ELCA) and achieve QFR > 0.80 without exclusion criteria such as STEMI or dialysis are the intended participants.

Probably not a fit

Patients with STEMI, on dialysis, with in‑stent restenosis, poor angiographic quality for QFR, a life expectancy under one year, or lesions that cannot be adequately modified or have post‑modification QFR ≤ 0.80 are unlikely to benefit from this comparison.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized interventional trial compares outcomes after using a drug‑coated balloon (DCB) versus a drug‑eluting stent (DES) in lesions with severe coronary calcification that have first undergone calcium modification by rotational atherectomy, intravascular lithotripsy, or excimer laser. Key outcomes include major adverse cardiovascular events (MACE) at one year, perioperative complications (for example side‑branch loss, perforation, no‑reflow, and periprocedural myocardial infarction), and quantitative flow ratio (QFR) measured one year after PCI. Patients must have a post‑modification QFR greater than 0.80 to be randomized, and if a flow‑limiting dissection occurs after DCB, a DES will be implanted. Thrombosis events in treated vessels will also be recorded and compared between groups.

Why it matters

Potential benefit: If successful, the approach could let some patients avoid permanent stent implantation while achieving similar one‑year outcomes, potentially reducing long‑term stent‑related complications.

How similar studies have gone: Previous research supports DCB use for in‑stent restenosis and some small‑vessel disease, but using DCB in heavily calcified de novo lesions after targeted calcium modification is relatively untested.

Who can join: the full rules

Show full inclusion / exclusion criteria 
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.

Where it's running

  • Zhongshan Hospital, Fudan University
    Shanghai, China     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov ↗ Find more trials like this →
Browse more
Coronary Calcification 3Shanghai Zhongshan Hospital 111
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.