Drug‑coated balloon versus drug‑eluting stent for severely calcified coronary arteries after calcium modification
Drug Coated Balloons Versus Drug-Eluting Stents for Severe Coronary Calcification After Optimal Calcium Modification Assessed by QFR (PRECISE CAL Study)
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 656 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07277114 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai
- Zhongshan Hospital, Fudan University — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Jianying Ma
- Email: ma.jianying@zs-hospital.sh.cn
- Phone: +86-64041990-5115
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.