New stent aims to tackle tricky heart blockages
NCT ID NCT07649798
First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times
Summary
This early study tests a new stent system designed to treat blockages at artery branch points in the heart. It involves 13 people with heart disease who need a procedure to open these blockages. The main goal is to see if the stent can be safely placed and work as intended.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
-
13 people
The number who actually took part.
- Started
-
Sep 2025
- Expected to finish
-
Nov 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
21 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Bifurcation coronary artery disease are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Cirugía Cardiovascular, Sanatorio Italiano
Asunción, Paraguay
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a cocktail of nerve blocks replace opioids after heart bypass?
- Could a Drug-Coated balloon beat stents for a common heart attack cause?
- Could cold climates shape heart healing after stents?
- Can a Community-Based rehab program boost heart recovery after a first attack?
- Can a new catheter make heart stenting safer and more effective?
- Smartphone apps and wearables could transform heart recovery