Poland-Italy Aortic Research Bridge Real World Registry (POWER)

March 18, 2026 updated by: Przemysław Nowakowski, American Heart of Poland

A Pragmatic, Observational, Multicenter Registry on the Implantation of the Tri Modular PERCUTEK Tycheseal™ Endograft System for the Treatment of Abdominal Aortic Aneurysm (AAA)

Objective To pragmatically collect and analyze patient-level clinical, procedural, and outcome data from participating centers in Italy and Poland on the use of the PERCUTEK Tycheseal™ stent-graft system for the endovascular repair of abdominal aortic aneurysms. The study aims to generate high-quality, real-world evidence on the technical success, safety, and mid-term outcomes of the device.

Study Design This is a pragmatic, observational, multicenter physician-initiated registry that will collect patient-level data for all eligible patients undergoing PERCUTEK Tycheseal™ device implantation. Each site will enter data into a standardized paper case report form (CRF), including demographic, anatomical, procedural, and follow-up variables. Sites will be expected to comply with data entry timelines and quality control checks. The total projected enrollment is 120-200 patients across all sites over an expected 18 month inclusion period.

The target enrollment is 120-200 patients across all participating sites.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Background and Rationale

Abdominal Aortic Aneurysm (AAA): Clinical Burden and Unmet Needs Abdominal aortic aneurysm (AAA) is a progressive and potentially fatal vascular disease defined as a localized dilatation of the abdominal aorta exceeding 1.5 times its normal diameter, typically ≥3.0 cm. The pathophysiology of AAA involves complex interplay between genetic predisposition, chronic inflammation, extracellular matrix degradation, and biomechanical wall stress. Risk factors for AAA include advanced age, male sex, smoking, hypertension, dyslipidemia, and family history. Notably, population based screening studies have shown that up to 5-8% of men over the age of 65 harbor asymptomatic AAAs, many of which are at risk of expansion and eventual rupture if left untreated. The clinical importance of timely diagnosis and treatment of AAA lies in its natural history: once the aneurysm reaches a critical threshold-commonly 5.5 cm in diameter in men or 5.0 cm in women-the risk of rupture increases substantially. Aneurysm rupture is associated with extremely high mortality, with up to 90% of patients dying before reaching the hospital or during emergency intervention. Consequently, elective repair is indicated in appropriately selected patients based on aneurysm size, growth rate, symptomatology, and anatomical feasibility.

Advances and Challenges in Endovascular Aneurysm Repair (EVAR) Over the past two decades, endovascular aneurysm repair (EVAR) has largely supplanted open surgical repair (OSR) as the preferred modality for treating infrarenal AAA in anatomically suitable patients. EVAR offers several perioperative advantages, including reduced operative blood loss, shorter procedure times, lower 30-day mortality rates, and faster postoperative recovery. These benefits make EVAR especially attractive for elderly patients and those with significant comorbidities who may not tolerate open surgery.

Despite these advantages, EVAR is not without limitations. Long-term surveillance is required due to risks of late complications such as graft migration, endoleak formation (particularly types I and III), aneurysm sac expansion, and device thrombosis. These complications may necessitate secondary interventions and contribute to long-term morbidity. Additionally, anatomical constraints such as short or highly angulated necks, calcification, thrombus burden, and tortuous iliac arteries may preclude the safeuse of some endograft systems. As a result, device selection plays a crucial role in procedural success and long-term outcomes.

The Poland-Italy Aortic Research Bridge Real World Registry (POWER) is a pragmatic, observational, multicenter registry designed to systematically collect real-world data on the use of the PERCUTEK Tycheseal™Tri-Modular Endograft System in patients undergoing endovascular repair of abdominal aortic aneurysms (AAA).

Study Type This is a non-randomized, open-label, post-market physician-initiated clinical investigation. It does not involve experimental treatments or random allocation of interventions, and no comparator arm is included.

Objectives

  • To assess technical success and safety outcomes associated with the use of the PERCUTEK Tycheseal™system.
  • To evaluate mid-term clinical outcomes, including aneurysm sac behavior, endoleak rates, and device-related complications over a follow-up period of up to 24 months.

Participating Countries and Sites

  • Multicenter registry with sites in Poland and Italy.
  • Sites must demonstrate documented experience in aortic endovascular repair.
  • Each participating center must have local ethics approval and assign a trained data manager and a site principal investigator, unless a general (e.g. national or regional) ethics committee approval is applicable.

Estimated Enrollment

• A total of 120-200 patients will be enrolled consecutively over approximately 18 months.

Each subject will be followed for up to 24 months post-implantation, with assessments at baseline, discharge, 1 month, 12 months and 24 months.

The PERCUTEK Tycheseal™Endograft System: Design Rationale The PERCUTEK Tycheseal™ system is a tri-modular stent graft platform designed for the treatment of infrarenal AAA. It consists of a main body and two iliac limb components, each optimized for precision deployment, modular adaptability, and enhanced seal zone conformity. The device is intended to address common anatomical challenges by accommodating a wide range of aortic neck diameters (main body proximal graft diameters: 20-36 mm, with 10-20% of oversizing), tolerating moderate angulation (up to 75°), and facilitating reliable fixation and sealing even in anatomically complex patients.

The PERCUTEK Tycheseal™ system features a low-profile delivery system, radiopaque markers for fluoroscopic visibility, and graft materials engineered for biocompatibility and durability. Early use in single-center case series and preliminary feasibility studies suggests that the device offers favorable deliverability, short procedure duration, and high technical success. However, robust, pragmatic, multicenter data in real-world settings are still lacking, which limits broader confidence in its long-term safety and performance.

Rationale for the POWER Registry The Poland-Italy Aortic Research Bridge Real World Registry (POWER) has been established to pragmatically evaluate the use of the PERCUTEK Tycheseal™ stent graft system in a real-world clinical environment across multiple high-volume European centers. This physician-initiated registry aims to fill a critical evidence gap by generating longitudinal, patient-level data on technical feasibility, clinical outcomes, and device-related complications over a 12-24- month period.

Several compelling factors justify the need for this registry:

  • Real-World Generalizability: Unlike tightly controlled randomized trials, the POWER Registry reflects actual clinical practice, encompassing diverse operator experience levels, institutional protocols, and patient anatomies.
  • Post-Market Surveillance: As the PERCUTEK Tycheseal™ system expands into routine use, structured post-market follow-up becomes essential to detect rare adverse events and performance trends.
  • Multinational Collaboration: By including centers from both Poland and Italy, the registry promotes transnational harmonization of endovascular standards and facilitates benchmarking of regional clinical outcomes.
  • Clinical Decision Support: The findings from this registry will provide procedural insights and safety benchmarks that can inform clinical decision-making, guideline development, and payer evaluations.

Through detailed documentation of implantation success, early and mid-term complications, and follow-up imaging, the POWER Registry will support an evidencebased understanding of the PERCUTEK Tycheseal™system's performance. The use of standardized paper CRFs, centralized data coordination, and optional site-level aggregate submissions ensures a flexible yet rigorous data capture approach. Ultimately, the POWER Registry aligns with contemporary regulatory and clinical imperatives for post-market device surveillance, and its findings are expected to directly contribute to the refinement of EVAR indications, device iteration, and patient centered care in AAA management.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Castel Volturno, Italy
      • Catania, Italy
        • Not yet recruiting
        • Centro Cuore Morgagni
        • Contact:
          • Vincenzo Monaca, Dr
        • Contact:
          • Daniele Sangrigoli, Dr
      • Pozzilli, Italy
        • Not yet recruiting
        • IRCCS Neuromed - Istituto Neurologico Mediterraneo
        • Contact:
      • Reggio Emilia, Italy
      • San Donato Milanese, Italy
        • Not yet recruiting
        • Policlinico San Donato
        • Contact:
  • Poland
      • Bialystok, Poland
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Białymstoku
        • Contact:
      • Bielsko-Biala, Poland
        • Recruiting
        • Szpital Wojewódzki w Bielsku-Białej
        • Contact:
      • Bytom, Poland
        • Recruiting
        • Wojewódzki Szpital Specjalistyczny nr 4
        • Contact:
      • Chrzanów, Poland
        • Recruiting
        • Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów
        • Contact:
      • Ełk, Poland
        • Recruiting
        • 118 Szpital Wojskowy z Przychodnią SPZOZ
        • Contact:
      • Gdynia, Poland
      • Kielce, Poland
      • Krakow, Poland
        • Recruiting
        • Bonifraterskie Centrum Medyczne
        • Contact:
      • Krakow, Poland
        • Recruiting
        • Krakowski Szpital Specjalistyczny im. JPII
        • Contact:
      • Lublin, Poland
        • Recruiting
        • Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
        • Contact:
      • Lublin, Poland
      • Lublin, Poland
        • Recruiting
        • Wojewódzki Szpital Specjalistyczny w Lublinie
        • Contact:
      • Opole, Poland
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Opolu
        • Contact:
      • Poznan, Poland
      • Przemyśl, Poland
        • Recruiting
        • Wojewódzki Szpital im. św. Ojca Pio
        • Contact:
      • Szczecin, Poland
        • Recruiting
        • Uniwersytecki Szpital Kliniczny nr 2 PUM
        • Contact:
      • Warsaw, Poland
      • Warsaw, Poland
        • Recruiting
        • Mazowiecki Szpital Bródnowski
        • Contact:
      • Warsaw, Poland
        • Recruiting
        • Narodowy Instytut Kardiologii
        • Contact:
      • Wodzisław Śląski, Poland
        • Recruiting
        • Wodzisławskie Centrum Medyczne
        • Contact:
      • Zielona Góra, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with abdominal aortic aneurysm

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Technical success of the PERCUTEK Tycheseal™ stent-graft implantation, defined as successful deployment at the intended site with the absence of immediate type I or III endoleaks and no requirement for unplanned conversion to open repair.
Time Frame: 12 months
12 months
Freedom from aneurysm sac enlargement, defined as no increase ≥5 mm in the maximum transverse aortic aneurysm diameter at 12 months compared to baseline imaging.
Time Frame: 12 month
12 month
Freedom from type I or III endoleaks, confirmed by Doppler ultrasound or angio CT at the 6- and 12-month follow-ups.
Time Frame: 6 and 12 months
6 and 12 months
Freedom from aneurysm rupture during the 12-month follow-up period.
Time Frame: 12 months
12 months
Freedom from stent-graft migration resulting in a serious adverse event or requiring secondary intervention.
Time Frame: 12 months
12 months
Freedom from any stent-graft occlusion at 12 months.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Aneurysm-related mortality at 12 months
Time Frame: 12 months
12 months
All-cause mortality
Time Frame: 30 days; 12 months
30 days; 12 months
Aneurysm sac regression >5 mm at 12 months compared to baseline.
Time Frame: 12 months
12 months
Major adverse events (MAEs) at 30 days, 12 months, and 24 months, including: Myocardial infarction, Stroke or transient ischemic attack, New-onset renal failure or dialysis requirement.
Time Frame: 30 days; 12 months; 24 months
30 days; 12 months; 24 months
All endoleaks (types I, II, III, or undefined origin) detected at 30 days, 12 months, and 24 months.
Time Frame: 30 days; 12 month; 24 months
30 days; 12 month; 24 months
Reinterventions, categorized as: For treatment of endoleaks, For stent-graft thrombosis or occlusion.
Time Frame: 24 months
24 months
Serious adverse device effects (SADEs) throughout the study period.
Time Frame: 24 months
24 months

Other Outcome Measures

Outcome Measure
Time Frame
Device performance metrics as rated by implanting physicians (e.g., ease of use, trackability, radiopacity).
Time Frame: 24 months
24 months
Medication adherence, particularly antiplatelet and anticoagulant regimens.
Time Frame: 24 months
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Heart of Poland

Investigators

  • Principal Investigator: Przemysław Nowakowski, MD,PhD, Prof, American Heart of Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Zong NC, Huang K, Yang X, Cai H. Expand the success of screening to reduce aortic aneurysm mortality: progress interpretation and new fronts. Trends Cardiovasc Med. 2025 May;35(4):221-229. doi: 10.1016/j.tcm.2024.12.004. Epub 2024 Dec 13. PMID: 39675687.
  • Ziaja K, Nowakowski P, Simka M. Ponowne wyciecie tetniaka aorty brzusznej--opis przypadku [Repeated excision of abdominal aortic aneurysm--case report]. Wiad Lek. 2000;53(11-12):701-5. Polish. PMID: 11247416.
  • Wierzejski W, Nowakowski P, Drobiński D. Ascending aortic dissection diagnosed with the use of point-of-care sonography. Case report. J Ultrason. 2014 Dec;14(59):428 34. doi: 10.15557/JoU.2014.0045. Epub 2014 Dec 30. PMID: 26673414; PMCID: PMC4579717.
  • Wang S, Fu W, Wang L. First in man: PERCUTEK Tianyi® stent-graft greatly facilitated in situ fenestration during thoracic aortic aneurysm endovascular repair. Eur Heart J Case Rep. 2024 Dec 9;9(1):ytae638. doi: 10.1093/ehjcr/ytae638. PMID: 39802051; PMCID: PMC11718307.
  • Troisi N, Pulli R, Donato G, Adami D, Bertagna G, Michelagnoli S, Berchiolli R; ALPHA Abdominal registry Collaborative Group *. Early and Midterm Outcomes of Endovascular Aneurysm Repair With Zenith Alpha Abdominal Stent-Graft: Results From a Multicenter Retrospective Tuscany Registry. J Endovasc Ther. 2025 Jun;32(3):794-801. doi: 10.1177/15266028231197151. Epub 2023 Aug 30. PMID: 37646124.
  • Stokmans RA, Teijink JA, Forbes TL, Böckler D, Peeters PJ, Riambau V, Hayes PD, van Sambeek MR. Early results from the ENGAGE registry: real-world performance of the Endurant Stent Graft for endovascular AAA repair in 1262 patients. Eur J Vasc Endovasc Surg. 2012 Oct;44(4):369-75. doi: 10.1016/j.ejvs.2012.07.005. Epub 2012 Jul 24. PMID: 22835762.
  • Sirignano P, Andreoli F, Gaggiano A, Accarino G, Tusini N, Benedetto F, Veroux P, Silingardi R, Taurino M, Speziale F; AFX2-LIVE Collaborative Study Group. Infrarenal Aortic Treatment With AFX2 Endograft: Results From a Multicentric, International, Non-Randomized, Prospective Registry-the AFX2-LIVE Study. J Endovasc Ther. 2024 Oct 6:15266028241284364. doi: 10.1177/15266028241284364. Epub ahead of print. PMID: 39369322.
  • Reyes Valdivia A, Pitoulias G, Criado FJ, Torsello G, Gandarias C, Austermann M, Pitoulias AG, Donas K. Multicenter European Registry for Patients with AAA Undergoing EVAR Evaluating the Performance of the 36-mm-Diameter Endurant Stent-Graft. Cardiovasc Intervent Radiol. 2017 Oct;40(10):1514-1521. doi: 10.1007/s00270-017-1665-6. Epub 2017 May 1. PMID: 28462441.
  • Rastogi V, Summers SP, Yadavalli SD, Perrier J, Allievi S, Jabbour G, Stangenberg L, de Bruin JL, Jones D, Ferran CJ, Verhagen HJM, Schermerhorn ML. Association between diabetes status and long-term outcomes following open and endovascular repair of infrarenal abdominal aortic aneurysms. J Vasc Surg. 2024 Dec;80(6):1685 1696.e1. doi: 10.1016/j.jvs.2024.08.030. Epub 2024 Aug 23. PMID: 39181338; PMCID: PMC11585419.
  • Nowakowski P, Uchto W, Stoliński J, Gubała M, Legut M. Endovascular treatment of infrarenal aortic aneurysm using the ANKURA stent graft - one-center case series. Postepy Kardiol Interwencyjnej. 2023 Mar;19(1):67-69. doi: 10.5114/aic.2023.124041. Epub 2023 Jan 11. PMID: 37090207; PMCID: PMC10114175.
  • Meuli L, Zimmermann A, Petersen JK, Fosbøl EL, Dabravolskaité V, Makaloski V, Eiberg JP, Køber LV, Resch TA. Risk Stratification and Treatment Selection in Patients With Asymptomatic Abdominal Aortic Aneurysms. JAMA Netw Open. 2025 Apr 1;8(4):e253559. doi: 10.1001/jamanetworkopen.2025.3559. PMID: 40193076; PMCID: PMC11976495.
  • Marone EM, Rinaldi LF, Brioschi C, Bracale UM, Modugno P, Maione M, Curci R, Filippi F, Piffaretti G, Gaggiano A, Palasciano G, Angiletta D, Michelagnoli S, Forliti E, Ercolini L, Pulli R; TIGRE REGISTRY GROUP. Endovascular Aortic Repair With the E Tegra Device: Preliminary Outcomes From a Multicenter National Registry. J Endovasc Ther. 2024 Aug 27:15266028241270861. doi: 10.1177/15266028241270861. Epub ahead of print. PMID: 39188184.
  • Kontopodis N, Gavalaki A, Galanakis N, Kantzas M, Ioannou C, Geroulakos G, Kakisis J, Antoniou GA. Systematic Review With Meta-Analysis of Endovascular Versus Open Repair of Abdominal Aortic Aneurysm Repair in the Young. J Endovasc Ther. 2025 Apr;32(2):276-289. doi: 10.1177/15266028231179419. Epub 2023 Jun 22. PMID: 37350089.
  • Hoshina K. A Multifaceted Approach to Abdominal Aortic Aneurysm. Ann Vasc Dis. 2025;18(1):24-00137. doi: 10.3400/avd.ra.24-00137. Epub 2025 Jan 21. PMID: 39877329; PMCID: PMC11774523.
  • Francisco-Azevedo J, Romana-Dias L, Ribeiro H, Dias-Neto M, Rocha-Neves J. Incidence of Myocardial Injury in Patients Submitted to Abdominal Aortic Aneurysm Repair: A Systematic Review and Meta-Analysis. Ann Vasc Surg. 2025 May 10;120:57-76. doi: 10.1016/j.avsg.2025.05.006. Epub ahead of print. PMID: 40349833.
  • Capó XF, García Reyes ME, Cánovas ÁS, Besalduch LS, Ruiz DF, Montoya SB; Vascular Advisory Committee - Catalan Health Service. Hospital Volume of Elective Abdominal Aortic Aneurysm Repair as a Predictor of Mortality After Ruptured Abdominal Aortic Aneurysm Repair. Eur J Vasc Endovasc Surg. 2024 Jul;68(1):30-38. doi: 10.1016/j.ejvs.2024.02.034. Epub 2024 Feb 29. PMID: 38428671.
  • Candell L, Tucker LY, Goodney P, Walker J, Okuhn S, Hill B, Chang R. Early and delayed rupture after endovascular abdominal aortic aneurysm repair in a 10-year multicenter registry. J Vasc Surg. 2014 Nov;60(5):1146-1153. doi: 10.1016/j.jvs.2014.05.046. Epub 2014 Jun 21. PMID: 24957409; PMCID: PMC4331642.
  • Besch A, Heckenkamp J, Adili F, Steinbauer M, Cotta L, Behrendt CA. Endovascular Treatment of Abdominal Aortic Aneurysm and Impact of Annual Caseload in the Quality Registry of the German Society for Vascular Surgery and Vascular Medicine (DGG). Eur J Vasc Endovasc Surg. 2025 May 10:S1078-5884(25)00382-X. doi: 10.1016/j.ejvs.2025.05.012. Epub ahead of print. PMID: 40354966.
  • Bachoo P, Verhoeven EL, Larzon T. Early outcome of endovascular aneurysm repair in challenging aortic neck morphology based on experience from the GREAT C3 registry. J Cardiovasc Surg (Torino). 2013 Oct;54(5):573-80. PMID: 24002386.
  • Álvarez Marcos F, Llaneza Coto JM, Camblor Santervás LA, Zanabili Al-Sibbai AA, Alonso Pérez M. Five Year Post-Endovascular Aneurysm Repair Aneurysm Sac Evolution in the GREAT Registry: an Insight in Diabetics Using Propensity Matched Controls. Eur J Vasc Endovasc Surg. 2024 Jun;67(6):912-922. doi: 10.1016/j.ejvs.2023.10.033. Epub 2023 Oct 26. PMID: 37898359.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2026

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2030

Study Registration Dates

First Submitted

March 12, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 20, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POWER-AAA-2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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