NCT04430114

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 5, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2022

Completed
Last Updated

November 14, 2022

Status Verified

November 1, 2022

Enrollment Period

1.7 years

First QC Date

June 9, 2020

Last Update Submit

November 10, 2022

Conditions

Aneurysm AbdominalAneurysm Thoracic

Outcome Measures

Primary Outcomes (3)

  • number of participants who obtain technical success

    number of surviving participants

    12 month

  • 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

  • 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

Study Arms (1)

TAAA spinal loop graft

EXPERIMENTAL
Device: branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms

Interventions

branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysmsDEVICE

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.

TAAA spinal loop graft

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • patients aged ≤ 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Raffaele Hospital

Milan, 20132, Italy

Location

MeSH Terms

Conditions

Aortic Aneurysm, AbdominalAortic Aneurysm, Thoracic

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 9, 2020

First Posted

June 12, 2020

Study Start

June 5, 2020

Primary Completion

March 1, 2022

Study Completion

March 1, 2022

Last Updated

November 14, 2022

Record last verified: 2022-11

Locations

IT(1)