Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures (PLD.REG.)

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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Brief Title

Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures

Official Title

A Physician-initiated, International, Multi-center, Retrospective and Prospective, Observational Registry of Patients Treated by Preloaded Fenestrated Stent-graft Designs for Complex Endovascular Aortic Procedures

Brief Summary

      The aim of the study is to evaluate the outcomes of the preloaded stent-graft design (PLD) in
      the routine treatment of para-renal and thoraco-abdominal aneurysms. Results and
      postoperative events are reported in accordance with the current reporting standards for
      endovascular aortic repair prepared and revised by the Ad Hoc Committee for Standardized
      Reporting Practices in Vascular Surgery of The Society for Vascular Surgery/American
      Association for Vascular Surgery.

      The Registry will include approximately 300 patients treated from January 2015 to May 2021
      (retrospective arm) and June 2021 to June 2023 (perspective arm) for the routine treatment of
      para-renal and thoraco-abdominal aneurysms. To reach 300 patients, the enrollments can be
      extended until June 2026.

Study Type

Observational

Primary Outcome

Clinical success

Condition

Renal Aneurysm

Intervention

Complex Endovascular Aortic Procedures treated by Preloaded Fenestrated Stent-graft Designs for

Study Arms / Comparison Groups

 Preloaded Fenestrated Stent-graft Designs for Endovascular Aortic Procedures
Description:  Patients presenting with an acute (up to two weeks from the onset) and subacute (between 3 and 12 weeks from the onset) type B dissection with a proximal suitable non-dissected landing zone in the aortic arch or descending thoracic aorta (supra-aortic trunks debranching may be employed to obtain an adequate proximal landing zone)

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

300

Start Date

October 30, 2022

Completion Date

December 31, 2023

Primary Completion Date

March 31, 2023

Eligibility Criteria

        Inclusion Criteria:

        -Patients presenting with an acute (up to two weeks from the onset) and subacute (between 3
        and 12 weeks from the onset) type B dissection with a proximal suitable non-dissected
        landing zone in the aortic arch or descending thoracic aorta (supra-aortic trunks
        debranching may be employed to obtain an adequate proximal landing zone

        Exclusion Criteria:

          -  Anatomy requiring sealing in the distal descending thoracic aorta may not be
             appropriate for a 50 cm sheath due to the risk of it being too short and the graft not
             reaching the intended landing zone;

          -  Celiac trunk or superior mesenteric branch design that makes the graft excessively
             long;

          -  Inability or refusal to give informed consent;

          -  Simultaneously participating in another investigative device or drug study;

          -  Frank rupture;

          -  Systemic infection (eg, sepsis);

          -  Allergy to stainless steel, polyester, solder (tin, silver), polypropylene, nitinol,
             or gold;

          -  Untreatable reaction to contrast, which, in the opinion of the investigator, cannot be
             adequately premedicated.

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +390226437381, [email protected]

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT05141123

Organization ID

Preloaded Registry

Responsible Party

Principal Investigator

Study Sponsor

IRCCS San Raffaele

Study Sponsor

, ,

Verification Date

June 2022