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New combo treatment for Rock-Hard arteries shows promise in clinical trial

NCT ID NCT07279987

Disease control Sponsor: Lin Zhao Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 methods to treat severely calcified coronary arteries: one uses a special balloon that inflates at very high pressure, and the other combines a rotating burr with sound waves to break up calcium. Researchers will enroll 162 adults with hardened arteries to see which approach leads to better stent placement and fewer complications. Participants will be followed for one year to track heart health and safety.

What this could mean

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

Active substance
Rotational atherectomy device, intravascular lithotripsy device, and super high-pressure balloon
What this could lead to
If successful, this could offer a safer and more effective way to open heavily calcified heart arteries, improving stent placement and reducing complications.
What could go wrong
This is an early-stage trial with only 162 participants, so results may not apply to everyone. Both techniques carry risks like artery damage or blockages.

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 162 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Dec 2028

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 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: * Age ≥18 years, able to understand the study purpose and voluntarily sign written informed consent * Coronary angiography confirmed severe calcified lesions (Mintz classification ≥Grade 2), with IVUS unable to pass or showing calcification grade ≥2 * Native coronary artery lesion * Target vessel diameter 2.5-4.0mm * Lesion length ≤30mm, suitable for rotational atherectomy * Clinical indication for PCI: Ischemic cardiomyopathy confirmed by functional testing (e.g., myocardial nuclear scan); Clinical presentation of stable or unstable angina with clear PCI indication * Planned rotational atherectomy as initial calcium modification technique * After rotational atherectomy (burr diameter ≤1.5mm), IVUS shows calcification grade still ≥2, or \<2 but 2.5mm non-compliant balloon cannot achieve adequate expansion at nominal pressure * Informed consent signed and agreement to participate in clinical trial * Able to comply with treatment and complete follow-up Exclusion Criteria: * Acute myocardial infarction (AMI) within 7 days, as condition may be unstable and increase periprocedural complication risk * Target vessel characteristics: Target vessel with thrombus formation, may increase intraoperative embolism risk; Target vessel with chronic total occlusion (CTO), unable to be treated by rotational atherectomy and calcium modification techniques; Target lesion is in-stent restenosis; Target lesion located in coronary artery bypass graft * Severe heart failure: left ventricular ejection fraction \<30%, poor tolerance to PCI surgery, may increase perioperative mortality risk * Previous treatment history: previous stent implantation or rotational atherectomy in the same target vessel, as complex lesion structure or confounding treatment effects may exist * Special medical history: Known contrast allergy or severe bleeding tendency (such as active gastrointestinal bleeding), may be unable to tolerate PCI surgery; Patients with other serious comorbidities, expected to be unable to complete 12-month follow-up (such as life expectancy \<12 months) * Pregnancy or lactation: pregnant or lactating women, as intraoperative radiation and drug effects may adversely affect mother and child * Participation in other clinical trials: patients simultaneously participating in other interventional clinical trials, to avoid mutual influence of different trial intervention measures

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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

  • Beijing Chaoyang Hospital,Capital Medical University

    Beijing, Beijing Municipality, 100020, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.