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NCT07162792
The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT
NA trial testing bioresorbable scaffold in Coronary Artery Disease(CAD) in 150 participants. Not yet recruiting.
30 December 2027
Quick facts
| Lead sponsor | Xuzhou Third People's Hospital |
|---|---|
| Phase | NA |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 150 |
| Start date | 23 October 2025 |
| Primary completion | 30 December 2027 |
| Estimated completion | 30 December 2028 |
Drugs / interventions tested
- bioresorbable scaffold
- drug-coated balloon
Conditions studied
- Coronary Artery Disease(CAD) — all drugs for Coronary Artery Disease(CAD) →
- de Novo Coronary Lesions — all drugs for de Novo Coronary Lesions →
Sponsor
Xuzhou Third People's Hospital
Who can join
Adults 18 to 80, any sex, with Coronary Artery Disease(CAD) or de Novo Coronary Lesions. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study plans to enroll 150 patients who are candidates for "intervention without implantation" therapy and they will be randomly assigned in a 1:1 ratio to either the new-generation Firesorb scaffold group (BRS group, N=75) or the drug-coated balloon group (DCB group, N=75). All enrolled patients will undergo angiographic follow-up at 1 year post-procedure, and serial follow-up (via telephone or outpatient visit) will be performed at 1 month, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years post-procedure. The primary study endpoint was percentage diameter stenosis at 1 year post-procedure.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07162792
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Coronary Artery Disease(CAD)
Currently open trials in the same condition.
- NCT07107568 — Assessment of Coronary Artery Disease Before Transcatheter Aortic Valve Replacement: A Randomized, Multicenter, Non-Infe · NA · recruiting
- NCT06843005 — Serial Coronary CTA-based Plaque Progression Detection for Management of Coronary Heart Disease · NA · recruiting
Other Xuzhou Third People's Hospital trials
Trials by the same sponsor.
- NCT06669195 — Intravascular Lithotripsy for Acute Stent Under-expansion in Calcified Coronary Lesions · NA · not yet recruiting
- NCT06669793 — Biolimus-Coated Balloon in de Novo Large Vessel Coronary Lesions · NA · not yet recruiting
- NCT06166459 — Yao Strategy for the Treatment of de Novo Medina 0,1,0 or 0,0,1 Bifurcation Lesion · NA · unknown
- NCT04375319 — OCT Evaluation of Early Vascular Repair in Patients With Non ST Elevation Acute Coronary Syndrome (NSTE-ACS) · NA · unknown
- NCT04641468 — Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China · NA · unknown
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 NCT07162792 (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 Xuzhou Third People's Hospital
- Last refreshed: 9 September 2025
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/NCT07162792.
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