Balloon vs stent: which works best for clogged arteries?

NCT ID NCT07369765

Disease control Sponsor: Biruni University Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares two ways to open completely blocked heart arteries (chronic total occlusion): a drug-coated balloon versus a drug-eluting stent. About 200 adults with coronary artery disease will be randomly assigned to one treatment. The goal is to see which approach keeps the artery open longer and reduces heart attacks or the need for repeat procedures.

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 or drug-eluting stent
What this could lead to: If successful, this could show that a drug-coated balloon is as good as or better than a stent for opening completely blocked heart arteries, offering a stent-free option.
What could go wrong: This is a relatively small, early-phase trial (200 people) comparing two existing devices, so any advantage may be modest. The balloon might not keep the artery open as well as a stent.

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

Aug 2025

Expected to finish

Aug 2027

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * • Definite or probable CTO as per CTO-ARC definition * CTO length ≥ 20 mm and ≤ 40 mm; * High likelihood (≥90 %) of CTO-PCI success (balance between CTO lesion complexity and operator expertise); * Successful treatment of any non-CTO lesions at least 1 month before randomization; * CTO lesion location in a vessel segment with diameter ≥ 2.5 mm; * Successful intraplaque (intraluminal) wiring (extraplaque tracking \< 10 mm or \< 50% of occlusion length) with no flow-limiting dissection and a TIMI flow ≥ 2 after initial predilation with NC balloon. Exclusion Criteria: * Life expectancy \< 1 year as result of non-cardiac conditions; * Multiple CTO lesions that require recanalization; * Target lesion is an in-stent CTO; * Angiographic grade 3 calcifications in the CTO segment (Appendix 2); * Recent acute coronary syndrome (\< 1 month); * Cardiogenic shock or inability to stay in supine position for long time; * Severe kidney failure (eGFR ≤ 30 mL/min); * Any planned non-CTO PCI \< 12 months after randomization; * Anticipated less compliance of the patients to complete the following or taking medical therapy; * Patient or legal representative unable or unwilling to provide written informed consent prior to study enrollment; * Pregnancy or childbearing age unless a recent pregnancy test is negative.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder

As listed by the trial registrant

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

Coronary artery disease

How to take part

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

The places running it

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

Balloon vs stent: which works best for clogged arteries?

What the study statuses mean