New stent study aims for faster healing in High-Risk heart patients
NCT ID NCT07230847
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study looks at two types of stents (small mesh tubes) placed in heart arteries to keep them open. It focuses on patients with acute coronary syndrome who also have a high risk of bleeding. The goal is to see how well the blood vessel heals around the stent one month after the procedure, using a special imaging technique called OCT. About 60 participants will be enrolled, and the results will help doctors understand which stent might be safer and more effective for this vulnerable group.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- BA9 (sirolimus derivative) coated on BioFreedom stent
- What this could lead to
- If successful, this could show that the BioFreedom stent helps blood vessels heal faster and safer in patients with high bleeding risk, potentially reducing complications.
- What could go wrong
- This is a small, early-stage study with only 60 participants, so results may not apply to everyone. The main risk is that the stent might not heal as well as expected, leading to blood clots or other issues.
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
-
About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2025
- Expected to finish
-
Mar 2027
An estimate. End dates often move.
- Lead sponsor
-
A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 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: 1. Age ≥18 years 2. Male or non-pregnant female 3. Acute coronary syndrome (ACS) patients requiring percutaneous coronary intervention (PCI) 4. No contraindications for coronary artery bypass grafting (CABG) 5. High bleeding risk (HBR) patients per ARC-HBR definition (meeting ≥1 major or 2 minor criteria): Major Criteria: * Expected long-term oral anticoagulation * Severe/end-stage chronic kidney disease (eGFR \<30 mL/min) * Moderate/severe anemia (Hb \<110 g/L) * Spontaneous bleeding requiring hospitalization/transfusion within 6 months (or recurrent) * Chronic bleeding diathesis * Moderate/severe thrombocytopenia pre-PCI (platelet count \<100×10⁹/L) * Liver cirrhosis with portal hypertension * Active malignancy in past 12 months (excluding non-melanoma skin cancer; defined as diagnosis/treatment within 12 months) * History of spontaneous intracranial hemorrhage * Traumatic intracranial hemorrhage within 12 months * Known cerebral arteriovenous malformation * Moderate/severe ischemic stroke within 6 months * Major surgery/severe trauma within 30 days pre-PCI * Planned non-deferrable major surgery during dual antiplatelet therapy Minor Criteria: * Age ≥75 years * Moderate chronic kidney disease (eGFR:30\~59 ml/min) * Mild anemia (male: Hb=110\~129 g/L; female: Hb=110\~119 g/L) * Spontaneous bleeding requiring hospitalization/transfusion within 6-12 months pre-PCI * Chronic NSAID/steroid use post-PCI * Ischemic stroke \>6 months pre-PCI 6. Capable of understanding trial objectives and providing informed consent Angiographic Inclusion Criteria: 1. Target lesion must be primary native coronary artery lesion 2. Target lesion with ≥70% diameter stenosis (visual estimate), or 50-70% diameter stenosis (visual estimate) with ischemic evidence 3. ≥1 non-target lesion requiring intervention 4. Non-target lesions eligible for elective treatment within 1 month Exclusion Criteria: General Exclusion Criteria: 1. Presence of ≥1 evidence of heart failure including: * NYHA Class III or higher, or * Killip classification ≥ Grade 2, or * Left ventricular ejection fraction (LVEF) ≤30% within 30 days pre-procedure (by echocardiography or intraoperative ventriculography) 2. Cardiogenic shock patients 3. Known allergies to: Aspirin / clopidogrel / ticagrelor / heparin, Contrast agents/drugs used in drug-eluting stents or contraindications to aspirin/ clopidogrel / ticagrelor 4. Life expectancy \<12 months or factors potentially compromising clinical follow-up 5. Participation in other drug/medical device trials prior to enrollment without reaching primary endpoint timelines 6. History of substance abuse (alcohol/cocaine/heroin, etc.) 7. Severe arrhythmias (e.g., high-risk ventricular premature contractions/ ventricular tachycardia) 8. Other medical conditions deemed unsuitable by investigators Angiographic Exclusion Criteria: 1. Left main coronary artery disease 2. Bypass graft lesions 3. Evidence of extensive thrombus in target vessel
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Acute coronary syndrome 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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Fuwai hospital, CAMS&PUMC
RECRUITINGBeijing, Beijing Municipality, 100037, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Tailoring cardiac rehab to each heart: can personalized training speed recovery?
- Can a 20-Minute playlist calm a heart attack Patient's nerves?
- A blood test at 50 could flag your risk of five diseases. can an app stop them?
- Can a common gout pill shield hearts after stents?
- Can a simple blood test flag hidden heart risks after stenting?
- A simple ultrasound test may sharpen heart attack risk predictions