MuLtibranchEd Graft for OPen RepAir of ThoRacoabdominal Aneurysms

Aneurysm Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430114
• Other study ID #: CLEOPATRA study
• Status: Completed
• Phase: N/A
• Start date: June 5, 2020
• Est. completion date: March 1, 2022

Study information

• Verified date: November 2022
• Source: IRCCS San Raffaele
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aneurysm
• Aneurysm Abdominal
• Aneurysm Thoracic
• Aortic Aneurysm, Abdominal
• Aortic Aneurysm, Thoracic

Intervention

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.

Locations

Country	Name	City	State
Italy	San Raffaele Hospital	Milano

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS San Raffaele

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants who obtain technical success	number of surviving participants	12 month
Primary	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	12 month
Primary	incidence of aneurysmal dilatation of visceral and replanted intercostal arteries	freedom from surgical / endovascular reoperation for aneurysmal dilatation of visceral and replanted intercostal arteries	12 month