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

NCT07649798 | Active Not Recruiting FDA Device

• 1 other identifier: 082825
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• MACE

  30-days, 6-months, 1-year, 2-years, and 3-years post index procedure

• TVF

  30-days, 6-months, 1-year, 2-years, and 3-years post index procedure

• Target Lesion Revascularization of the Side Branch

  30-days, 6-months, 1-year, 2-years, and 3-years post index procedure

• Stent thrombosis

  6-months, 1-year, 2-years, and 3-years post index procedure

• Acute Success

  Index procedure

Study Arms (1)

Patients with coronary bifurcation lesions

EXPERIMENTAL

Patients undergoing PCI to treat a bifurcation lesion

Device: MD-SBA DES System

Interventions

MD-SBA DES System DEVICE

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.

Also known as: Percutaneous coronary Intervention (PCI)

Patients with coronary bifurcation lesions

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Advanced Bifurcation Systems Inc.: lead

Study Sites (1)

Cirugía Cardiovascular, Sanatorio Italiano

Asunción, Paraguay

Location

MeSH Terms

Conditions

Myocardial Ischemia

Interventions

Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Randy E David, PhD

  Advanced Bifurcation Systems Inc.

  STUDY DIRECTOR

• Mehran Khorsandi, MD

  Advanced Bifurcation Systems Inc.

  STUDY CHAIR

• Adrian Ebner, MD

  Sanatorio Italiano, Asunción, Paraguay

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2026
• First Posted: June 16, 2026
• Study Start: September 16, 2025
• Primary Completion: November 19, 2025
• Study Completion (Estimated): November 19, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)