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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Angioplasty; Percutaneous Coronary Intervention (PCI); Ischemic Heart Disease (IHD); Bifurcation Coronary Artery Disease
• Intervention / Treatment: Device: MD-SBA DES System

Detailed Description

This is a prospective, single-arm, single-center initial (EFS) clinical study enrolling subjects with symptomatic ischemic heart disease due to a de novo coronary bifurcation lesion. The objective is to obtain initial insights into the clinical safety of the device-specific aspects of the procedure; whether the device can be successfully delivered and implanted; whether there are any operator technique challenges with device use; human factors; clinical safety of the device and whether the device performs in accordance with its intended purpose.

All enrolled subjects will be treated with the study device during the index procedure and followed after treatment to assess procedural success, clinical safety, and device performance. Follow-up is conducted through 3 years.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Cirugía Cardiovascular, Sanatorio Italiano

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Be 21 years of age or older. Have symptomatic ischemic heart disease or objective evidence of reduced blood flow to the heart.

Be eligible for PCI, also known as coronary stenting. Have a new coronary artery narrowing involving a branch point that meets the study's angiographic requirements.

Be willing and able to complete study follow-up. Be able to provide written informed consent. If able to become pregnant, have a negative pregnancy test before the procedure and agree not to become pregnant or breastfeed for 1 year.

Exclusion Criteria:

Are currently participating in another investigational drug or device study that could interfere with this study.

Had a coronary intervention within 30 days before the planned study procedure. Need a planned additional coronary procedure soon after the study procedure. Had a prior stent placed close to the target lesion. Have a target lesion that requires certain other treatment devices before stent placement, other than balloon angioplasty or intravascular lithotripsy.

Have a serious medical condition that could limit participation, follow-up, or interpretation of the study results.

Have a life expectancy of less than 3 years. Have a condition requiring chronic immunosuppressive therapy or have a severe autoimmune or immunosuppressive condition.

Have significantly reduced heart pumping function. Had a recent acute heart attack, unless certain laboratory values have returned to acceptable levels.

Had a stroke or transient ischemic attack within the past 6 months. Have certain abnormal blood test results, including low white blood cell count, low neutrophil count, low platelet count, or significantly reduced kidney function.

Have active stomach or intestinal bleeding, active peptic ulcer disease, a bleeding disorder, or cannot receive blood transfusions.

Have a known allergy or contraindication to required medications, contrast dye, or study device materials that cannot be adequately managed.

Are pregnant, breastfeeding, or planning to become pregnant within 1 year after the study procedure.

Have coronary anatomy that is not suitable for the study device, as determined during coronary angiography (This may include blood clot in the target lesion, severe vessel tortuosity, severe calcification, certain lesion locations, or other significant disease in the target vessel).

Are unable or unwilling, in the opinion of the study doctor, to comply with the study requirements.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with coronary bifurcation lesions; Patients undergoing PCI to treat a bifurcation lesion	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.; Other Names: Percutaneous coronary Intervention (PCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Success	To determine whether the device can be successfully delivered and implanted, as measured by attainment of <30% final residual stenosis of the target lesion and no in-hospital major adverse cardiac events (MACE).	Periprocedural

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MACE	Percentage of subjects with major adverse cardiac events, defined as cardiac death, myocardial infarction, emergency coronary artery bypass surgery, or clinically driven target lesion revascularization. Components of MACE, including cardiac death and myocardial infarction, may also be summarized.	30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
TVF	Percentage of subjects with target vessel failure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization.	30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
Target Lesion Revascularization of the Side Branch	Percentage of subjects requiring repeat treatment of the side branch by percutaneous or surgical methods.	30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
Stent thrombosis	Percentage of subjects with late stent thrombosis.	6-months, 1-year, 2-years, and 3-years post index procedure
Acute Success	Percentage of subjects with successful device delivery and target lesion treatment, including final residual stenosis <30% and adequate side branch flow.	Index procedure
Side Branch Access	Percentage of subjects with TIMI-3 flow in the side branch and/or need to re-cross the side branch after study device use.	Index procedure
Bleeding / Vascular Complications	Percentage of subjects with bleeding or vascular complications.	Hospital discharge
Procedure Time	Duration of the index procedure in minutes	Index procedure
Fluoroscopy Time	Total fluoroscopy duration during index procedure in minutes	Index procedure
Contrast Volume	Total volume of contrast media used during index procedure in milliliters	Index procedure

Collaborators and Investigators

• Sponsor: Advanced Bifurcation Systems Inc.
• Investigators: Study Director: Randy E David, PhD, Advanced Bifurcation Systems Inc.; Study Chair: Mehran Khorsandi, MD, Advanced Bifurcation Systems Inc.; Principal Investigator: Adrian Ebner, MD, Sanatorio Italiano, Asunción, Paraguay

Study record dates

Study Major Dates

• Study Start (Actual): September 16, 2025
• Primary Completion (Actual): November 19, 2025
• Study Completion (Estimated): November 19, 2028

Study Registration Dates

• First Submitted: May 21, 2026
• First Submitted That Met QC Criteria: June 11, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Myocardial Ischemia; Surgical Procedures, Operative; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Minimally Invasive Surgical Procedures; Percutaneous Coronary Intervention
• Other Study ID Numbers: 082825

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes