Coronary AngioplastyNCT07649798
Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH Feasibility Study)
A study testing MD-SBA DES System in people with Coronary Angioplasty and Bifurcation Coronary Artery Disease, run by Advanced Bifurcation Systems Inc. at 1 site in Paraguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Coronary Angioplasty, Bifurcation Coronary Artery Disease, Ischemic Heart Disease (IHD)
- What is being tested?
- MD-SBA DES System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteParaguay
- Study dates
- 16 Sep 2025to 19 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System for Bifurcation Lesions (First-in-Human, Feasibility Study)
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.
Read the detailed description
This is a prospective, single-arm, single-center initial feasibility 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.
- Conditions
- Coronary Angioplasty, Bifurcation Coronary Artery Disease, Ischemic Heart Disease (IHD), Percutaneous Coronary Intervention (PCI)
- Being tested
- MD-SBA DES System
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MD-SBA DES SystemDevice
Also called Percutaneous coronary Intervention (PCI)
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with coronary bifurcation lesions | Experimental | Patients undergoing PCI to treat a bifurcation lesion Receives: Device: MD-SBA DES System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Periprocedural
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
Stent thrombosis
Percentage of subjects with late stent thrombosis.
Measured: 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.
Measured: 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.
Measured: Index procedure
Bleeding / Vascular Complications
Percentage of subjects with bleeding or vascular complications.
Measured: Hospital discharge
Procedure Time
Duration of the index procedure in minutes
Measured: Index procedure
Fluoroscopy Time
Total fluoroscopy duration during index procedure in minutes
Measured: Index procedure
Contrast Volume
Total volume of contrast media used during index procedure in milliliters
Measured: Index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2026
- Study start16 Sep 2025
- Primary completion19 Nov 2025
- Study completion19 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary AngioplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Bifurcation Systems Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Randy E David, PhD, Study director, Advanced Bifurcation Systems Inc.Mehran Khorsandi, MD, Study chair, Advanced Bifurcation Systems Inc.Adrian Ebner, MD, Principal investigator, Sanatorio Italiano, Asunción, Paraguay
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649798
- Sponsor's protocol ID
- 082825
- Status last verified
- Jun 2026
- First submitted
- 21 May 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System for Bifurcation Lesions (First-in-Human, Feasibility Study)
- ClinicalTrials.gov ID
- NCT07649798
- Acronym / sponsor ID
- 082825
- Conditions
- Coronary Angioplasty, Bifurcation Coronary Artery Disease, Ischemic Heart Disease (IHD), Percutaneous Coronary Intervention (PCI)
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Advanced Bifurcation Systems Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Sep 2025 (actual)
- Primary completion
- 19 Nov 2025 (actual)
- Study completion
- 19 Nov 2028 (estimated)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, single-arm, single-center initial feasibility 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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with coronary bifurcation lesions | Experimental | Device: MD-SBA DES SystemPatients undergoing PCI to treat a bifurcation lesion |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MD-SBA DES SystemAlso: Percutaneous coronary Intervention (PCI)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. | Device | Patients with coronary bifurcation lesions |
Primary outcome
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).
10 secondary outcomes
MACE
Time frame: 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
Target Lesion Revascularization of the Side Branch
Time frame: 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
Acute Success
Time frame: Index procedure
Side Branch Access
Time frame: Index procedure
Bleeding / Vascular Complications
Time frame: Hospital discharge
Procedure Time
Time frame: Index procedure
Fluoroscopy Time
Time frame: Index procedure
Contrast Volume
Time frame: Index procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Randy E David, PhD study director
Advanced Bifurcation Systems Inc.
Mehran Khorsandi, MD study chair
Advanced Bifurcation Systems Inc.
Adrian Ebner, MD principal investigator
Sanatorio Italiano, Asunción, Paraguay
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MD-SBA DES System in people with Coronary Angioplasty and Bifurcation Coronary Artery Disease, run by Advanced Bifurcation Systems Inc. at 1 site in Paraguay.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure Success (time frame: Periprocedural). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.