NCT04885816

Drug-eluting Balloon Versus Drug-eluting Stent for High Bleeding Risk Angioplasty

Drug-Eluting Balloon Versus Drug-eluting Stent On de Novo coRonary Artery Disease in Patients With High Bleeding Risk

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Instituto Nacional de Cardiologia Ignacio Chavez · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• High Bleeding Risk
• Coronary Artery Disease (CAD)
• Percutaneous Coronary Intervention (PCI)

Interventions

Type	Name	Description
DEVICE	Drug Eluting Balloon (DEB)	Size (diameter and length) will be chosen at operator's discretion aid by simple angiography, quantitative coronary analysis (QCA), or intravascular image; so that the lesion previously prepared and 2 mm at each end are covered by DEB, and the diameter and pressure used aims a balloon to artery ratio of 1. In case of significant recoil (more than 30% for main vessels and 50% for side vessels), coronary perforation or flow limiting dissection, provisional stent will be implanted with a stent to artery ratio of 1.1 with stent post-dilatation when indicated. Device will be used in accordance with the CE mark instructions. DAPT will be given for a month with aspirin and a P2Y12 inhibitor (clopidogrel will be favored). Single anti-platelet therapy (SAPT) with aspirin will be continued thereafter.
DEVICE	Drug Eluting Stents (DES)	Size (diameter and length) will be chosen at operator's discretion aid by simple angiography, quantitative coronary analysis (QCA), or intravascular image; so that the lesion previously prepared and 2 mm at each end are covered by DES with an stent to artery ratio of 1.1. Post-dilatation will be performed when indicated. Devices will be used in accordance with the CE mark instructions. DAPT will be indicated according to actual international guidelines.

Timeline

• Start date: 2021-04-20
• Primary completion: 2021-09-29
• Completion: 2021-09-29
• First posted: 2021-05-13
• Last updated: 2021-10-26

Locations

1 site across 1 country: Mexico