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. 2025 Feb 8;8(1):11.
doi: 10.1186/s42155-025-00523-4.

Percutaneous Closure Device Controlled INCRAFT Stentgraft Implantation Registry (PUCCINI)

T Engelen  1 , R Hoogervorst  2 , K DeLoose  3 , L C van Dijk  2 , R S van Eps  4 , R B van Tongeren  5 , H T Veger  4 , L Maene  6 , W Stomp  2 , O R Wikkeling  7 , S J C Klink  2 , W van den Eynde  8 , J J Wever  4 , H van Overhagen  2
Affiliations

Percutaneous Closure Device Controlled INCRAFT Stentgraft Implantation Registry (PUCCINI)

T Engelen et al. CVIR Endovasc. .

Abstract

Background: Percutaneous endovascular repair (PEVAR) of infra-renal abdominal aortic aneurysms (AAA) is increasingly being performed due to the development of low profile endografts and the use of percutaneous closure devices. The feasibility and safety of the use of the INCRAFT AAA Stentgraft System and the ProGlide vascular closure system was assessed.

Methods: The PUCCINI trial prospectively enrolled patients undergoing elective repair of infrarenal AAA at 3 centres in the Netherlands and 3 centres in Belgium. Patients underwent PEVAR with endograft implantation followed by closure using the ProGlide closure device. Procedural success rates, complications and 30-day follow-up outcomes were collected.

Results: A total of 93 patients, 87% male, were enrolled. The mean aneurysmal diameter was 53.9 ± 10.2 mm. Successful ProGlide placement was achieved in 97.2% in the right and 89.8% in the left groin. Successful closure was achieved in 92.4% of right and 90% of left groins. One patient required surgical access and two surgical closure. Average blood loss was 155.6 ± 175.5ml. Blood transfusion was not required. Average length of hospital stay was 2.1 ± 1.3 days. Post-implantation endoleaks were present in 37 (40.2%) patients (type 1: 12, type 2: 25). At 30-days there was no aneurysmal growth and no deaths. Follow-up imaging showed endoleaks in 39 (41.9%) patients. (type 1:8, type 2:29, type 3:2).

Conclusion: The results from the PUCCINI trial demonstrate that the use of a low profile endoprosthesis for treatment of infrarenal AAA with percutaneous closure has a high rate of technical success and low rates of periprocedural complication.

Keywords: Infra-renal abdominal aortic aneurysm; Low-profile endograft; Percutaneous endovascular repair (PEVAR); Suture-mediated closure.

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Conflict of interest statement

Declarations. Ethics approval and consent to participate: The study protocol was approved by the Medical Ethics Review Committee South-West Holland and the study was registered at the Netherlands Trial Register under trial ID NL-8044. All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. Informed consent was obtained from all individual participants included in the study. Consent for publication: Consent for publication was obtained for every individual person’s data included in the study. Competing interests: The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Inclusion criteria by vessel and abdominal aortic aneurysm characteristics
See this image and copyright information in PMC

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