Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2025-12-25 @ 8:55 PM
Study NCT ID:
NCT06866756
Status:
RECRUITING
Last Update Posted:
2025-08-22
First Post:
2025-02-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon
Sponsor:
Andres Iñiguez Romo
Organization:
Study Overview
Official Title:
Experience in Percutaneous Coronary Intervention With Sirolimus Drug-Coated Balloon and Paclitaxel Drug-Coated Balloon
Status:
RECRUITING
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Cardiovascular disease (CVD) is the leading cause of mortality worldwide, with a significant burden in low- and middle-income countries. Acute coronary syndrome (ACS) is often the first clinical manifestation of CVD, representing a major cause of morbidity and mortality. Global variations exist in revascularization rates and long-term mortality following ACS. It is estimated that 12% of disability-adjusted life years are lost annually due to CVD. Drug-coated balloons (DCB) constitute a promising technology to overcome few disadvantages of current latest generation of drug-eluting stents (DES). The safety of these devices has been proven previously. However, there is few data regarding its efficacy in a broad spectrum of clinical setting and patient population.
Hypothesis:
The sirolimus-coated drug-eluting balloon demonstrates comparable safety and efficacy to the paclitaxel-coated balloon in patients undergoing angioplasty for coronary artery disease.
Primary 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.
Hypothesis:
The sirolimus-coated drug-eluting balloon demonstrates comparable safety and efficacy to the paclitaxel-coated balloon in patients undergoing angioplasty for coronary artery disease.
Primary 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: