Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH Feasibility Study) (NCT07649798) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Initial Study of a MOTHER-DAUGHTER SIDE-BRANCH ACCESS™ DES System (FIH Feasibility Study)
Paraguay13 participantsStarted 2025-09-16
Plain-language 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.
Who can participate
Age range
21 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 o…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying a brand-new 'Mother-Daughter Side-Branch Access' stent system for bifurcation coronary artery disease — can you explain what makes treating a coronary bifurcation so technically challenging, and whether my specific blockage is even located at a branch point where this device would be relevant?
2Since this is listed as a First-In-Human Early Feasibility Study with a primary outcome of 'Procedure Success,' what does that actually mean for what's known — or not yet known — about how safe and effective this device is compared to stenting approaches you already use for my condition?
3The trial is currently active but no longer enrolling new patients — does that mean results might become available soon, and could those findings realistically change the treatment options you'd recommend for me?
4Given that this is a very early-stage study focused on whether the procedure works at a technical level, would standard PCI with currently approved stents or other established treatments be a more appropriate starting point for me right now?
5Are there specific features of my coronary anatomy, overall health, or other factors that would make me a good or poor candidate for a device designed for bifurcation lesions like this, regardless of whether this particular trial is an option?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.