Last reviewed · How we verify
NCT04885816: DEBORA
Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty
NA trial testing Drug Eluting Balloon (DEB) in High Bleeding Risk in 5 participants. Terminated before completion.
29 September 2021
Quick facts
| Lead sponsor | Instituto Nacional de Cardiologia Ignacio Chavez |
|---|---|
| Phase | NA |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 20 April 2021 |
| Primary completion | 29 September 2021 |
| Estimated completion | 29 September 2021 |
| Sites | 1 location across Mexico |
Drugs / interventions tested
- Drug Eluting Balloon (DEB)
- Drug Eluting Stents (DES)
Conditions studied
- High Bleeding Risk — all drugs for High Bleeding Risk →
- Coronary Artery Disease (CAD) — all drugs for Coronary Artery Disease (CAD) →
- Percutaneous Coronary Intervention (PCI) — all drugs for Percutaneous Coronary Intervention (PCI) →
Sponsor
Instituto Nacional de Cardiologia Ignacio Chavez — full company profile →
Who can join
18 and older, any sex, with High Bleeding Risk or Coronary Artery Disease (CAD). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Randomized, single-blind, single-center, non-inferiority clinical trial to compare target lesion failure (TLF) at 12 months in high bleeding risk patients undergoing elective coronary percutaneous intervention comparing limus-eluting balloon vs. limus-eluting stents.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04885816
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for High Bleeding Risk
Currently open trials in the same condition.
- NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
- NCT07125417 — Non-antithrombotic Versus. Single Antiplatelet Therapy Following Left Atrial Appendage Closure · Phase 4 · recruiting
Other Instituto Nacional de Cardiologia Ignacio Chavez trials
Trials by the same sponsor.
- NCT06881940 — Cardiac Rehabilitation Program on the Prevention of Cardiotoxicity in Breast Cancer Patients Undergoing Treatment With A · NA · not yet recruiting
- NCT06342141 — Empagliflozin for No-reflow Phenomenon in PCI for STEMI · Phase 2 · active not recruiting
- NCT06521307 — Impact of Nicotinamide Riboside (NR) on Kidney Function in Patients Undergoing Cardiac Surgery · NA · not yet recruiting
- NCT06584734 — Effect of Intradialytic Exercise on Left Ventricular Diastolic Function in Hemodialysis Patients · NA · active not recruiting
- NCT06013813 — Conventional vs. Distal Radial Access Outcomes in STEMI Patients Treated by PCI · 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 NCT04885816 (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 Instituto Nacional de Cardiologia Ignacio Chavez
- Last refreshed: 26 October 2021
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/NCT04885816.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing