An interventional study of MD-SBA DES System in Coronary Angioplasty, Bifurcation Coronary Artery Disease and Ischemic Heart Disease (IHD), sponsored by Advanced Bifurcation Systems Inc.. Active, not recruiting at 1 site in Paraguay. Open to participants aged 21 Years and older. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Advanced Bifurcation Systems Inc. · Not applicable, Interventional, and Device feasibility
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.
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.
1,123 studies on the registry are indexed under Myocardial Ischemia; 177 are open to participants now.
This study's enrollment of 13 is below the median of 116 across 622 interventional studies indexed under Myocardial Ischemia.
Browse Myocardial Ischemia studies →This is the only study on the registry with Advanced Bifurcation Systems Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 . 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 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 of less than 3 years. Have a condition requiring chronic therapy or have a severe 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 within the past 6 months. Have certain abnormal blood test results, including low white blood cell count, low , low 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 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.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TIA (transient ischaemic attack)
A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.
Stroke symptoms need emergency care at once, even if they go away.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Percutaneous coronary Intervention (PCI)
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).
Time frame: Periprocedural
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.
Time frame: 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.
Time frame: 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.
Time frame: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
Stent thrombosis
Percentage of subjects with late stent thrombosis.
Time frame: 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.
Time frame: 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.
Time frame: Index procedure
Bleeding / Vascular Complications
Percentage of subjects with bleeding or vascular complications.
Time frame: Hospital discharge
Procedure Time
Duration of the index procedure in minutes
Time frame: Index procedure
Fluoroscopy Time
Total fluoroscopy duration during index procedure in minutes
Time frame: Index procedure
Contrast Volume
Total volume of contrast media used during index procedure in milliliters
Time frame: Index procedure
Plan to share: No
No publications or documents are linked to this record.
Ran from Sep 2025 to primary completion in Nov 2025, 2 months.
Of 37 industry-sponsored interventional studies with no phase under Myocardial Ischemia, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 58. This study's 2 months is below that.
Counting every sponsor, half of 192 studies reached it within 34 months; a quarter within 15 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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