New combo treatment for Rock-Hard arteries shows promise in clinical trial
NCT ID NCT07279987
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
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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
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About 162 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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: * 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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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.
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- Heart drug study cancelled before it began