Back to resultsMuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms
Primary Purpose
Aneurysm Abdominal, Aneurysm Thoracic
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms
Sponsored by
About this trial
This is an interventional other trial for Aneurysm Abdominal
Eligibility Criteria
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
Sites / Locations
- San Raffaele Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
TAAA spinal loop graft
Arm Description
Outcomes
Primary Outcome Measures
number of participants who obtain technical success
number of surviving participants
incidence of thrombosis of the prosthetic branches, visceral arteries and replanted intercostal arteries
freedom from thrombosis of the prosthetic branches,visceral arteries and replanted intercostal arteries
incidence of aneurysmal dilatation of visceral and replanted intercostal arteries
freedom from surgical / endovascular reoperation for aneurysmal dilatation of visceral and replanted intercostal arteries
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04430114
Brief Title
MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms
Official Title
DediCated MuLtibranchEd DacrOn Graft for OPen RepAir of ThoRacoabdominal Aneurysms - CLEOPATRA Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 5, 2020 (Actual)
Primary Completion Date
March 1, 2022 (Actual)
Study Completion Date
March 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aneurysm Abdominal, Aneurysm Thoracic
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAAA spinal loop graft
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms
Intervention Description
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 Outcome Measure Information:
Title
number of participants who obtain technical success
Description
number of surviving participants
Time Frame
12 month
Title
incidence of thrombosis of the prosthetic branches, visceral arteries and replanted intercostal arteries
Description
freedom from thrombosis of the prosthetic branches,visceral arteries and replanted intercostal arteries
Time Frame
12 month
Title
incidence of aneurysmal dilatation of visceral and replanted intercostal arteries
Description
freedom from surgical / endovascular reoperation for aneurysmal dilatation of visceral and replanted intercostal arteries
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
San Raffaele Hospital
City
Milano
ZIP/Postal Code
20132
Country
Italy
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms
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