MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms

November 10, 2022 updated by: Bertoglio Luca, IRCCS San Raffaele

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Italy
      • Milano, Italy, 20132
        • San Raffaele Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TAAA spinal loop graft
Device: branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of participants who obtain technical success
Time Frame: 12 month
number of surviving participants
12 month
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
12 month
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
12 month

Collaborators and Investigators

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

Sponsor

IRCCS San Raffaele

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)

June 5, 2020

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

March 1, 2022

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 14, 2022

Last Update Submitted That Met QC Criteria

November 10, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLEOPATRA study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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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