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NCT07277114
DCB vs DES for Severe Coronary Calcification After Optimal Modification Assessed by QFR
NA trial testing rotational atherectomy (RA) in Coronary Calcification in 656 participants. Currently enrolling.
31 December 2028
Quick facts
| Lead sponsor | Shanghai Zhongshan Hospital |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 656 |
| Start date | 1 February 2026 |
| Primary completion | 31 December 2028 |
| Estimated completion | 31 December 2030 |
| Sites | 1 location across China |
Drugs / interventions tested
- rotational atherectomy (RA)
- excimer laser coronary angioplasty (ELCA)
- Intravascular Lithotripsy (IVL)
Conditions studied
- Coronary Calcification — all drugs for Coronary Calcification →
Sponsor
Shanghai Zhongshan Hospital
Who can join
18 and older, any sex, with Coronary Calcification. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07277114
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Coronary Calcification
Currently open trials in the same condition.
- NCT07417150 — CAlcified Coronary Lesions Identification & Quantification With X Rays · NA · recruiting
- NCT07000045 — Intravascular Lithotripsy With or Without Rotational Atherectomy for Coronary Calcified Nodule Treatment · NA · recruiting
- NCT06678594 — Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification · recruiting
Other Shanghai Zhongshan Hospital trials
Trials by the same sponsor.
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- NCT07531368 — BBAP With CS Mapping Guidance · NA · not yet recruiting
- NCT07501104 — Neoadjuvant Pucotenlimab Combined With Lenvatinib and Temozolomide in Resectable Stage IIB/III Acral Melanoma · Phase 2 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07277114 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shanghai Zhongshan Hospital
- Last refreshed: 2 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07277114.
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