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OpenTrials
Completed

NCT Number: NCT04430114

MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms

The objective of the study is the evaluation of the technical success and clinical outcomes of the surgical treatment of thoraco-abdominal aortic aneurysms treated by Jotec "TAAA spinal loop graft" "custom made "CE equivalent" branched prosthesis, compared with the patient cohort already treated with standard and / or bench-top prostheses Gelweave ™ Coselli Thoracoabdominal Grafts.

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Key information

Conditions

Aneurysm Abdominal Aneurysm Aneurysm Thoracic Aortic Aneurysm Aortic Aneurysm, Abdominal Aortic Aneurysm, Thoracic Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Raffaele Hospital

Milan, 20132, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients aged ≥ 18 years;
  • patients candidates for surgical treatment of thoraco-abdominal aorta of the II and III type sec. Crawford using "TAAA spinal loop graft" "custom made CE equivalent" prosthesis

Exclusion criteria

  • patients aged ≤ 18 years

Treatment and study plan

branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms

Device

Jotec "TAAA spinal loop graft" "custom made CE equivalent" branched prosthesis, compared with the cohort of patients already treated with standard prostheses and / or Gelweave ™ Coselli Thoracoabdominal Grafts.

Primary outcomes

  1. number of participants who obtain technical success

    Time frame: 12 month

    number of surviving participants

  2. incidence of thrombosis of the prosthetic branches, visceral arteries and replanted intercostal arteries

    Time frame: 12 month

    freedom from thrombosis of the prosthetic branches,visceral arteries and replanted intercostal arteries

  3. incidence of aneurysmal dilatation of visceral and replanted intercostal arteries

    Time frame: 12 month

    freedom from surgical / endovascular reoperation for aneurysmal dilatation of visceral and replanted intercostal arteries

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Official study title

DediCated MuLtibranchEd DacrOn Graft for OPen RepAir of ThoRacoabdominal Aneurysms - CLEOPATRA Study

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 12, 2020
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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