Coronary Artery Disease (CAD) Clinical Trial
Official title:
Drug-Eluting Balloon Versus Drug-eluting Stent On de Novo coRonary Artery Disease in Patients With High Bleeding Risk
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.
Drug Eluting Stents (DES) are the devices of choice for coronary angioplasty, including in patients with high-bleeding risk. Different studies have been done to determine which strategy improves bleeding outcomes without risking the benefit of stenting. Different Double Anti-Platelet Therapy (DAPT) durations in different devices have shown that it is safe to reduce DAPT, with an increase in ischemic events but a better net clinical outcome. Safety and efficacy of Drug Eluting Balloons (DEB) were proved when it was compared with Bare Metal Stents (BMS) in de-novo coronary lesions by presenting no events of target vessel closure after treatment. Our hypothesis is that treating this group of high-bleeding risk patients with DEB will be no-inferior in terms of target vessel failure at 12 months when compared with DES for treatment of de-novo coronary lesions in high bleeding risk population, reducing incidence of significant bleeding events with DAPT reduction. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05292079 -
CAPTURER PMCF Study ( rEPIC04D )
|
||
| Recruiting |
NCT05292118 -
Navitian PMCF Study ( rEPIC04C )
|
||
| Recruiting |
NCT05292014 -
ANGIOLITE PMCF Study ( rEPIC04F )
|
||
| Recruiting |
NCT05292092 -
Essential Pro PMCF Study ( rEPIC04E )
|
||
| Completed |
NCT05292105 -
NC Xperience PMCF Study( rEPIC04B)
|
||
| Terminated |
NCT01443754 -
Hybrid Revascularisation by Combined Coronary Artery Bypass Graft (CABG) and PCI in Multivessel Coronary Disease
|
N/A | |
| Completed |
NCT01435031 -
EXPERT CTO: Evaluation of the XIENCE PRIME™ LL and XIENCE Nano™ Everolimus Eluting Coronary Stent Coronary Stents, Performance, and Technique in Chronic Total Occlusions
|
N/A | |
| Completed |
NCT00783302 -
Study in Subjects Suspected of Having CAD Undergoing VISIPAQUE-enhanced CCTA as Part of Their Routine Medical Care
|
N/A | |
| Completed |
NCT00543400 -
Evaluation of M118 in Percutaneous Coronary Intervention (EMINENCE)
|
Phase 2 | |
| Completed |
NCT05516784 -
Impact of CYP2C19 Genotype-guided Clopidogrel and Ticagrelor Treatment on Platelet Function Test and Metabolomics Profile
|
Phase 4 | |
| Completed |
NCT02873052 -
MyoVista Measurements in Patients With Atherosclerosis and CAD
|
||
| Terminated |
NCT02984891 -
Optical Coherence Tomography (OCT) Intravascular Ultrasound (IVUS) Dual Imaging
|
||
| Completed |
NCT05292144 -
Xperience Pro PMCF Study
|
||
| Completed |
NCT02554292 -
Post Market Surveillance of SeQuent Please Neo With Scoring Balloon
|
||
| Active, not recruiting |
NCT06052319 -
A Study to Assess the Engagement and Usefulness of Care4Today Digital Platform for Disease Management in Coronary Artery Disease (CAD) and/or Peripheral Artery Disease (PAD) Population
|
||
| Completed |
NCT00265525 -
Evaluation of a Web-based Intervention to Promote Physical Activity in Patients With Heart Disease.
|
Phase 3 | |
| Completed |
NCT03570697 -
Imaging of Coronary Plaques in Participants Treated With Evolocumab
|
Phase 3 | |
| Terminated |
NCT05508893 -
Screening for Coronary Artery Disease USing Primary Evaluation With Coronary CTA in Aviation Medicine (SUSPECT)
|
N/A | |
| Completed |
NCT02341664 -
Patient and Provider Assessment of Lipid Management Registry
|
||
| Completed |
NCT02098772 -
Phase III Study Comparing Two Methods of Cardioplegia in Aortic Valve Surgery Custodiol-N Versus Custodiol
|
Phase 3 |