Poland-Italy Aortic Research Bridge Real World Registry

NCT07476196 | Recruiting

• 1 other identifier: POWER-AAA-2025
• Study Type: observational
• Target: 200
• Locations: 2 countries
• Sites: 26

Brief Summary

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.

Conditions

Abdominal Aortic Aneurysm

Keywords

Abdominal aortic aneurysm; Endovascular Aneurysm Repair; PERCUTEK Tycheseal™; vascular disease; stent graft

Outcome Measures

Primary Outcomes (6)

• 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.

  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.

  12 month

• Freedom from type I or III endoleaks, confirmed by Doppler ultrasound or angio CT at the 6- and 12-month follow-ups.

  6 and 12 months

• Freedom from aneurysm rupture during the 12-month follow-up period.

  12 months

• Freedom from stent-graft migration resulting in a serious adverse event or requiring secondary intervention.

  12 months

• Freedom from any stent-graft occlusion at 12 months.

  12 months

Secondary Outcomes (7)

• Aneurysm-related mortality at 12 months

  12 months

• All-cause mortality

  30 days; 12 months

• Aneurysm sac regression >5 mm at 12 months compared to baseline.

  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.

  30 days; 12 months; 24 months

• All endoleaks (types I, II, III, or undefined origin) detected at 30 days, 12 months, and 24 months.

  30 days; 12 month; 24 months

Other Outcomes (2)

• Device performance metrics as rated by implanting physicians (e.g., ease of use, trackability, radiopacity).

  24 months

• Medication adherence, particularly antiplatelet and anticoagulant regimens.

  24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with abdominal aortic aneurysm

You may qualify if:

• 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
• Age \>18 years
• Signed informed consent
• Pregnancy test for premenopausal women

You may not qualify if:

• 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

Sponsors & Collaborators

• American Heart of Poland: lead

Study Sites (26)

Clinica Pineta Grande

Castel Volturno, Italy

NOT YET RECRUITING

Centro Cuore Morgagni

Catania, Italy

NOT YET RECRUITING

IRCCS Neuromed - Istituto Neurologico Mediterraneo

Pozzilli, Italy

NOT YET RECRUITING

Arcispedale Santa Maria Nuova

Reggio Emilia, Italy

NOT YET RECRUITING

Policlinico San Donato

San Donato Milanese, Italy

NOT YET RECRUITING

Uniwersytecki Szpital Kliniczny w Białymstoku

Bialystok, Poland

RECRUITING

Szpital Wojewódzki w Bielsku-Białej

Bielsko-Biala, Poland

RECRUITING

Wojewódzki Szpital Specjalistyczny nr 4

Bytom, Poland

RECRUITING

Małopolska Cardiovascular Center, Polish-American Heart Clinic in Chrzanów

Chrzanów, Poland

RECRUITING

118 Szpital Wojskowy z Przychodnią SPZOZ

Ełk, Poland

RECRUITING

Szpital im. Św. Wincentego a Paulo

Gdynia, Poland

RECRUITING

Wojewódzki Szpital Zespolony

Kielce, Poland

RECRUITING

Bonifraterskie Centrum Medyczne

Krakow, Poland

RECRUITING

Krakowski Szpital Specjalistyczny im. JPII

Krakow, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

Lublin, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny Nr 4

Lublin, Poland

RECRUITING

Wojewódzki Szpital Specjalistyczny w Lublinie

Lublin, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Opolu

Opole, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu

Poznan, Poland

RECRUITING

Wojewódzki Szpital im. Św. Ojca Pio

Przemyśl, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny Nr 2 PUM

Szczecin, Poland

RECRUITING

Mazowiecki Szpital Bródnowski

Warsaw, Poland

RECRUITING

Narodowy Instytut Kardiologii

Warsaw, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne WUM

Warsaw, Poland

RECRUITING

Wodzisławskie Centrum Medyczne

Wodzisław Śląski, Poland

RECRUITING

Szpital Uniwersytecki im. Karola Marcinkowskiego

Zielona Góra, Poland

RECRUITING

Related Publications (20)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Vascular Diseases

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Cardiovascular Diseases; Aortic Diseases

Study Officials

• Przemysław Nowakowski, MD,PhD, Prof

  American Heart of Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Przemysław Nowakowski, MD, PhD, Prof

CONTACT

(+48) 32 758 69 01; nowakowski.mcsn@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD, Professor

Study Record Dates

• First Submitted: March 12, 2026
• First Posted: March 17, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2030
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

PL (21); IT (5)