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Which heart procedure spares tiny vessels? study compares two Calcium-Busting techniques

NCT ID NCT07699965

Knowledge-focused Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 13, 2026 · Last updated Jul 14, 2026 · Updated 1 time

Summary

This study compares two procedures—rotational atherectomy and intravascular lithotripsy—used to treat severe calcium deposits in heart arteries. The goal is to see how each technique affects the tiny blood vessels (microcirculation) of the heart and whether one leads to better long-term outcomes. Researchers will follow about 590 patients for one year after their procedure, tracking heart-related events like heart attack or need for repeat treatment.

What this could mean

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

What this could lead to
If one procedure is found to better protect tiny heart blood vessels, it could guide doctors to choose the safer technique for patients with severe calcium buildup.
What could go wrong
This is an observational study, not a randomized trial, so results may be influenced by other factors. It also only follows patients for one year.

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.

Participants

About 590 people

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

Started

Jan 2018

Expected to finish

Sep 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.

Who is studied

Consecutive patients who underwent RA or IVL due to serve calcification during the PCI between January 1, 2018, and October 31, 2024.

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: Consecutive patients who underwent RA or IVL due to serve calcification during the PCI. Severe calcification was defined angiographically as radiopacities visible on both sides of the vessel lumen before contrast injection, or by intravascular ultrasound (IVUS) as a circumferential arc of calcification ≥270° extending for ≥5 mm in length- Exclusion Criteria: encompassed the presence of severe calcification treated with RA and IVL, in-stent restenosis and suboptimal angiographic image quality

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Conditions

The condition(s) this trial relates to.

coronary atherosclerosis coronary microvascular disorder

As listed by the trial registrant

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

Coronary artery calcification Coronary microcirculation dysfunction Intravascular lithotripsy

Contacts and locations

Locations

  • The Second Affiliated Hospital of Zhejiang University School of Medicine 88 Jiefang Road

    Hangzhou, Zhejiang, 310009, China

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