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New Stent-Graft for aortic aneurysm tested in Real-World registry

NCT ID NCT07476196

Disease control Sponsor: American Heart of Poland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This registry is tracking the use of the PERCUTEK Tycheseal stent-graft in up to 200 patients with abdominal aortic aneurysms. The goal is to see how well the device works in everyday practice, focusing on successful deployment, freedom from leaks or rupture, and overall safety. Participants will be followed for 12 months to monitor outcomes.

What this could mean

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

Active substance
PERCUTEK Tycheseal stent-graft system
What this could lead to
If successful, this registry could confirm that the Tycheseal stent-graft is a safe and effective option for treating abdominal aortic aneurysms, supporting its wider use.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less conclusive. The device may still carry risks like endoleaks or migration, and long-term outcomes are not yet known.

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 200 people

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

Started

Mar 2026

Expected to finish

Mar 2030

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

Patients with abdominal aortic aneurysm

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.

Anatomical Inclusion Criteria (as per IFU): * Morphologically suitable aneurysm * Neck length ≥ 10 mm * Neck diameter suitable for 20-36 mm body (considering 10-20% of oversizing) * Neck angle: infrarenal ≤ 75° * Distal seal zone ≥ 10 mm * Iliac arteries 8-20 mm diameter Patient Inclusion Criteria: * Age \>18 years * Signed informed consent * Pregnancy test for premenopausal women Exclusion Criteria: * Anatomical unsuitability * Subject has a life expectancy \< 1 year * Circumferential thrombus in neck * Ruptured aneurysm * Renal arteries from aneurysm sac * Dominant IMA with obstructed visceral vessels * Internal iliac artery aneurysms (unless pre-treated) * Subject has a known contraindication dual antiplatelets therapy or contrast media, * Selected patients with chronic kidney failure (CKF) can undergo EVAR using standard contrast or CO2 as contrast agent. * Previous aortoiliac surgery or EVAR * Recent stroke/MI (\< 3 months) * Allergy to device materials

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Conditions

The condition(s) this trial relates to.

abdominal aortic aneurysm vascular disorder

As listed by the trial registrant

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

Abdominal aortic aneurysm

How to take part

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

  1. The places running it

    26 sites in 2 countries. 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

  • 118 Szpital Wojskowy z Przychodnią SPZOZ

    RECRUITING

    Ełk, Poland

  • Arcispedale Santa Maria Nuova

    NOT_YET_RECRUITING

    Reggio Emilia, Italy

  • Bonifraterskie Centrum Medyczne

    RECRUITING

    Krakow, Poland

  • Centro Cuore Morgagni

    NOT_YET_RECRUITING

    Catania, Italy

  • Clinica Pineta Grande

    NOT_YET_RECRUITING

    Castel Volturno, Italy

  • IRCCS Neuromed - Istituto Neurologico Mediterraneo

    NOT_YET_RECRUITING

    Pozzilli, Italy

  • Krakowski Szpital Specjalistyczny im. JPII

    RECRUITING

    Krakow, Poland

  • Mazowiecki Szpital Bródnowski

    RECRUITING

    Warsaw, Poland

  • Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów

    RECRUITING

    Chrzanów, Poland

  • Narodowy Instytut Kardiologii

    RECRUITING

    Warsaw, Poland

  • Policlinico San Donato

    NOT_YET_RECRUITING

    San Donato Milanese, Italy

  • Szpital Uniwersytecki im. Karola Marcinkowskiego

    RECRUITING

    Zielona Góra, Poland

  • Szpital Wojewódzki w Bielsku-Białej

    RECRUITING

    Bielsko-Biala, Poland

  • Szpital im. Św. Wincentego a Paulo

    RECRUITING

    Gdynia, Poland

  • Uniwersytecki Szpital Kliniczny Nr 2 PUM

    RECRUITING

    Szczecin, Poland

  • Uniwersytecki Szpital Kliniczny Nr 4

    RECRUITING

    Lublin, Poland

  • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

    RECRUITING

    Lublin, Poland

  • Uniwersytecki Szpital Kliniczny w Białymstoku

    RECRUITING

    Bialystok, Poland

  • Uniwersytecki Szpital Kliniczny w Opolu

    RECRUITING

    Opole, Poland

  • Uniwersytecki Szpital Kliniczny w Poznaniu

    RECRUITING

    Poznan, Poland

  • Uniwersyteckie Centrum Kliniczne WUM

    RECRUITING

    Warsaw, Poland

  • Wodzisławskie Centrum Medyczne

    RECRUITING

    Wodzisław Śląski, Poland

  • Wojewódzki Szpital Specjalistyczny nr 4

    RECRUITING

    Bytom, Poland

  • Wojewódzki Szpital Specjalistyczny w Lublinie

    RECRUITING

    Lublin, Poland

  • Wojewódzki Szpital Zespolony

    RECRUITING

    Kielce, Poland

  • Wojewódzki Szpital im. Św. Ojca Pio

    RECRUITING

    Przemyśl, Poland

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