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Balloons may beat stents for tough heart blockages

NCT ID NCT07463664

Disease control Sponsor: The First Affiliated Hospital of Zhengzhou University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two treatments for people with completely blocked heart arteries (chronic total occlusions). One group gets a drug-coated balloon, with or without a stent; the other gets standard stents. The goal is to see if the balloon approach keeps arteries open just as well, while possibly reducing the number of stents needed. About 200 participants will be followed for at least 9 months with repeat imaging.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
drug-coated balloon (DCB) and drug-eluting stent (DES)
What this could lead to
If successful, this could offer a stent-free or stent-reduced option for treating chronic total blockages in heart arteries, potentially lowering long-term complications.
What could go wrong
This is a mid-stage trial with 200 participants, so results may not apply to all patients. The procedure carries standard risks like vessel injury or re-blockage.

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 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

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: * Patient voluntarily participates in the study and has provided written informed consent. * Presence of clinical indication for Percutaneous Coronary Intervention (PCI) of the Chronic Total Occlusion (CTO) (e.g., symptoms of angina pectoris or evidence of myocardial ischemia). * Target lesion is located in a de novo coronary artery. * Angiographically confirmed CTO (TIMI grade 0 flow), with evidence supporting an occlusion duration of ≥ 3 months. * Successful guidewire crossing of the target CTO lesion has been achieved during the index procedure. * After adequate vessel preparation: Distal TIMI grade 3 flow has been restored; Target lesion residual diameter stenosis is \< 50% (e.g., by visual estimate or QCA as per protocol); Absence of flow-limiting dissection or other complications requiring immediate stent implantation. * Target vessel Reference Vessel Diameter (RVD) is between 2.25 mm and 4.0 mm (inclusive, assessed by visual estimate or QCA/IVUS as per protocol). * In the judgment of the interventional operator, the lesion is deemed suitable for treatment with both a Drug-Coated Balloon (DCB)-based strategy and a Drug-Eluting Stent (DES)-only strategy. * Patient is able and willing to comply with the study protocol requirements, including the specified follow-up schedule. * Female patients of childbearing potential must have a negative pregnancy test prior to enrollment and agree to use an effective method of contraception throughout the study period. Exclusion Criteria: * Target CTO lesion is the culprit vessel responsible for the presenting Acute Myocardial Infarction (AMI). * Patient is in cardiogenic shock. * Presence of severe heart failure (New York Heart Association \[NYHA\] Class IV) or Left Ventricular Ejection Fraction (LVEF) \< 30%. * History of stroke or Transient Ischemic Attack (TIA) within the previous 3 months. * Known high risk of bleeding or contraindication to Dual Antiplatelet Therapy (DAPT). * Presence of severe hepatic impairment and/or severe renal impairment (e.g., estimated Glomerular Filtration Rate \[eGFR\] \< 30 ml/min/1.73m² or requirement for chronic dialysis). * Known hypersensitivity or contraindication to required study medications (e.g., antiplatelet agents, contrast media), DCB/DES drug coatings, or device materials (e.g., stent alloys, polymers). * Target lesion located in an unprotected left main coronary artery, a saphenous vein graft, or an arterial graft. * Presence of severe lesion calcification that prevents adequate vessel expansion despite attempted lesion preparation techniques (e.g., rotational atherectomy, intravascular lithotripsy). * Target lesion is a CTO within a previously stented segment (In-Stent Restenosis \[ISR\] or In-Stent Thrombosis \[IST\]). * Failed attempt at CTO recanalization during the index procedure (i.e., failure to cross the lesion with a guidewire or failure to restore TIMI grade 3 flow). * Occurrence of a complication after vessel preparation that necessitates immediate stent implantation (e.g., flow-limiting dissection, perforation requiring a covered stent). * Concurrent enrollment in another interventional clinical trial that may interfere with the study endpoints or assessments. * Female patient is pregnant or breastfeeding. * Patient judged by the investigator to be unsuitable for the study for any reason, including anticipated poor compliance with the protocol.

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Conditions

The condition(s) this trial relates to.

arterial occlusion coronary artery disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic total occlusion (CTO) Chronic total occlusions of coronary arteries Coronary artery disease (CAD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    18 sites. 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

  • Anyang District Hospital

    RECRUITING

    Anyang, Henan, 455000, China

  • Fuwai Hospital Chinese Academy of Medical Sciences (CAMS)

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 100037, China

  • Huaihe Hospital of Henan University

    RECRUITING

    Kaifeng, Henan, 475000, China

  • Jincheng People's Hospital

    RECRUITING

    Jincheng, Shanxi, 048026, China

  • Kaifeng Central Hospital

    RECRUITING

    Kaifeng, Henan, 475000, China

  • Nanyang City Center Hospital

    NOT_YET_RECRUITING

    Nanyang, Henan, 473000, China

  • People's Hospital of Zhengzhou

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450053, China

  • Puyang People's Hospital

    RECRUITING

    Puyang, Henan, 457099, China

  • The First Affiliated Hospital of Henan University of CM

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450000, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    RECRUITING

    Luoyang, Henan, 471003, China

  • The People's Hospital of Jiaozuo

    NOT_YET_RECRUITING

    Jiaozuo, Henan, 454002, China

  • The Second People's Hospital of Pingdingshan

    RECRUITING

    Pingdingshan, Henan, 467000, China

  • The second people's Hospital of Jiyuan

    RECRUITING

    Jiyuan, Henan, 454000, China

  • Tianjin Fourth Central Hospital

    NOT_YET_RECRUITING

    Tianjin, Tianjin Municipality, 300074, China

  • Xinyang Central Hospital

    NOT_YET_RECRUITING

    Xinyang, Henan, 464000, China

  • Yellow River Sanmenxia hospital

    NOT_YET_RECRUITING

    Sanmenxia, Henan, 472000, China

  • Zhengzhou Central Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, 450000, China

  • Zhoukou Central Hospital

    RECRUITING

    Zhoukou, Henan, 466000, China

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