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New stent aims to tackle tough heart blockages

NCT ID NCT07491107

Disease control Sponsor: Scitech Produtos Medicos SA 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 2 times

Summary

This registry will follow 2000 people with complex coronary artery disease who receive the Inspiron EVO drug-eluting stent. The stent is designed to be easier to deliver and stronger than standard stents. Researchers will track how well the stent works and whether it reduces heart attacks, death, 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
Inspiron EVO Drug-Eluting Stent
What this could lead to
If successful, this could show that the Inspiron EVO stent is a safe and effective option for treating complex coronary blockages, improving outcomes for patients with challenging heart disease.
What could go wrong
This is an observational registry, not a randomized trial, so results may be less definitive. The study is not yet recruiting, and real-world outcomes may vary. Risks include typical stent complications like blood clots or re-narrowing.

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 2,000 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Patients with symptomatic ischemic heart disease due to lesions in native coronary arteries and restenotic lesions treated with the Inspiron™ EVO Drug-Eluting Stent.

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: * Individuals aged 18 years or older presenting with complex coronary lesions requiring percutaneous coronary intervention (PCI). * Individuals who provide consent and are willing to comply with the follow-up protocol. * Individuals who received treatment with the Inspiron™ EVO Stent. * Individuals with lesions ≥ 30 mm in length (Subprotocol 1). * Individuals with significantly calcified coronary lesions (moderate to severe according to the ACC/AHA classification B1, B2, or C), with or without indication for lesion preparation techniques (Subprotocol 2). * Individuals with multivessel coronary artery disease (≥2 affected coronary vessels, with at least one vessel of small diameter ≤2.5 mm) (Subprotocol 3). * Individuals included in Subprotocol 1, 2, or 3. The evaluated segment must be accessible to the IVUS (Intravascular Ultrasound) catheter (Subprotocol 4). Exclusion Criteria: * Lesions in saphenous vein grafts or internal mammary grafts. * Contraindication to the use of a drug-eluting stent. * Individuals who were treated during the index procedure with any stent other than the Inspiron™ EVO Stent.

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Conditions

The condition(s) this trial relates to.

coronary artery disorder coronary atherosclerosis coronary stenosis

As listed by the trial registrant

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

Calcific coronary arteriosclerosis Complex coronary lesions Coronary artery disease (CAD) Multivessel coronary artery disease Small vessel ischemic disease Stenosis coronary

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

  • Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)

    Porto Alegre, Rio Grande do Sul, 90610000, Brazil

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