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ACTIVE NOT RECRUITING
NCT07649798
NA

Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH EFS)

Sponsor: Advanced Bifurcation Systems Inc.

View on ClinicalTrials.gov

Summary

This first in human early feasibility study is designed to evaluate the feasibility MD-SBA DES in subjects undergoing percutaneous coronary intervention (PCI) to treat bifurcation lesions.

Official title: Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System for Bifurcation Lesions (First-in-Human, Early Feasibility Study)

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

13

Start Date

2025-09-16

Completion Date

2028-11-19

Last Updated

2026-06-16

Healthy Volunteers

No

Interventions

DEVICE

MD-SBA DES System

The MD-SBA DES System is a single use, minimally invasive combination product that consists of a cobalt chromium metal coronary stent, coated with sirolimus in a PEA/BHT matrix, on a rapid exchange (RX) delivery system.

Locations (1)

Cirugía Cardiovascular, Sanatorio Italiano

Asunción, Paraguay