Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Objective: To assess the safety and efficacy of paclitaxel- vs. sirolimus-coated drug-eluting balloon over 12 months in patients undergoing coronary angioplasty for in-stent restenosis or small-vessel stenosis. Secondary

Objectives: To compare the efficacy (freedom from target vessel failure) of both balloons at 12 months. To evaluate the safety of paclitaxel- vs. sirolimus-coated balloon in coronary revascularization at 12 months. Study

Design: Study Type: Prospective, single-center, analytical cohort study. Population: Patients undergoing angioplasty with paclitaxel- or sirolimus-coated drug-eluting balloons according to standard clinical practice. Inclusion Criteria: Patients with De novo lesion and in stent reestenosis. Study Period: From September 2021 to September 2026 or until the required sample size is achieved. Study Importance: This study will provide comparative evidence on the use of paclitaxel- and sirolimus-coated DCBs in coronary revascularization. The findings may contribute to future clinical recommendations for the optimal use of DCBs in patients with coronary artery disease.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients with De novo lesion and in stent reestenosis.

Locations
Other Locations
Spain
Hospital Álvaro Cunqueiro
RECRUITING
Vigo
Contact Information
Primary
Víctor A Jiménez DÍaz, MD, MPH
victor.alfonso.jimenez.diaz@sergas.es
+34986825564
Backup
Andrés Iñiguez Romo, MD, PhD
andres.iniguez.romo@sergas.es
+34986825564
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 479
Treatments
Sirolimus-Coated Balloon
Patients with coronary artery disease treated with Sirolimus-Coated Balloon
Paclitaxel-Coated Balloon
Patients with coronary artery disease treated with Paclitaxel-Coated Balloon
Sponsors
Leads: Andres Iñiguez Romo

This content was sourced from clinicaltrials.gov