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

June 11, 2026 updated by: Advanced Bifurcation Systems Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
13

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Procedure Success
Time Frame: Periprocedural
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
MACE
Time Frame: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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
Time Frame: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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
Time Frame: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
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
Time Frame: 6-months, 1-year, 2-years, and 3-years post index procedure
Percentage of subjects with late stent thrombosis.
6-months, 1-year, 2-years, and 3-years post index procedure
Acute Success
Time Frame: Index procedure
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
Time Frame: Index procedure
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
Time Frame: Hospital discharge
Percentage of subjects with bleeding or vascular complications.
Hospital discharge
Procedure Time
Time Frame: Index procedure
Duration of the index procedure in minutes
Index procedure
Fluoroscopy Time
Time Frame: Index procedure
Total fluoroscopy duration during index procedure in minutes
Index procedure
Contrast Volume
Time Frame: Index procedure
Total volume of contrast media used during index procedure in milliliters
Index procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Advanced Bifurcation Systems Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 16, 2025

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 19, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 19, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 21, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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