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New stent study aims for faster healing in High-Risk heart patients

NCT ID NCT07230847

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

    RECRUITING

    Beijing, Beijing Municipality, 100037, China

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