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NCT04641468
Clinical Efficacy and Safety of a Prospective, Multicenter Drug Coated Balloon for Left Main Artery Disease in China
NA trial testing DCB in Coronary Diseases in 30 participants. Status unknown.
31 December 2020
Quick facts
| Lead sponsor | Xuzhou Third People's Hospital |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 30 |
| Start date | 1 November 2018 |
| Primary completion | 31 December 2020 |
| Estimated completion | 31 December 2021 |
| Sites | 1 location across China |
Drugs / interventions tested
- DCB
Conditions studied
- Coronary Diseases — all drugs for Coronary Diseases →
- Left Main Coronary Artery Disease — all drugs for Left Main Coronary Artery Disease →
- Bifurcation Lesions — all drugs for Bifurcation Lesions →
Sponsor
Xuzhou Third People's Hospital
Who can join
Adults 18 to 75, any sex, with Coronary Diseases or Left Main Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a prospective and observational study. Patients with primary mediana 010 or 001 left main bifurcation lesions were treated with drug ball coated balloon from November 2018 to November 2020 in four hospitals in Huaihai area. The clinical characteristics, pathological changes, operation process and perioperative drug treatment data were collected. Clinical follow-up included hospitalization, postoperative telephone or outpatient follow-up. Objective to compare the safety and efficacy of drug-eluting balloon and drug-eluting stent implantation alone in the treatment of primary mediana 010 or 001 left main bifurcation lesions.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Long-Term Clinical Outcomes After Percutaneous Coronary Intervention With Drug-Coated Balloon-Only Strategy in <i>de novo</i> Lesions of Large Coronary Arteries.
Hu FW, Chang S, Li Q, Zhu YX, et al · · 2022 · cited 16× · PMID 35911516 · DOI 10.3389/fcvm.2022.882303
Verify or expand the search:
- PubMed search for NCT04641468
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT05750771 — Comparison of DCB and DES for Severe Calcification of de Novo Lesion in Elderly CHD · NA · completed
- NCT02963649 — IN.PACT BTK Randomized Study to Assess Safety and Efficacy of IN.PACT 014 vs. PTA · NA · completed
Other Xuzhou Third People's Hospital trials
Trials by the same sponsor.
- NCT07162792 — The Safety and Efficacy of New-Generation BRS vs. DCB for De Novo Large Coronary Artery Lesions: A Prospective RCT · NA · not yet recruiting
- 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
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 NCT04641468 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 27 November 2020
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/NCT04641468.
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