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

NCT07649798 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2026-06-29

No results posted yet for this study

Summary

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

Conditions

  • Coronary Angioplasty
  • Bifurcation Coronary Artery Disease
  • Ischemic Heart Disease (IHD)
  • Percutaneous Coronary Intervention (PCI)

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.

Sponsors & Collaborators

  • Advanced Bifurcation Systems Inc.

    lead INDUSTRY

Principal Investigators

  • Randy E David, PhD · Advanced Bifurcation Systems Inc.

  • Mehran Khorsandi, MD · Advanced Bifurcation Systems Inc.

  • Adrian Ebner, MD · Sanatorio Italiano, Asunción, Paraguay

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-16
Primary Completion
2025-11-19
Completion
2028-11-19
FDA Device
Yes

Countries

  • Paraguay

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07649798 on ClinicalTrials.gov