NCT05896397

Brief Summary

The purpose of this study is to evaluate the safety and performance of Cook's various Custom-Made Stent-graft Devices (CMD) used for endovascular treatment of the aorta and related diseases by collecting information on the real-world use of the devices. The study results will be used to support the continuation of the CMDs on the market. In addition, the study will support the manufacturers obligation for post market product surveillance as well as Cook's technology development.

Trial Health

83
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
6 countries

18 active sites

Status
recruiting

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 Progress39%
May 2023Dec 2030

First Submitted

Initial submission to the registry

May 31, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

May 31, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

July 8, 2025

Status Verified

July 1, 2025

Enrollment Period

3.6 years

First QC Date

May 31, 2023

Last Update Submit

July 7, 2025

Conditions

Complex Abdominal Aortic AneurysmThoracoabdominal Aortic AneurysmAortic Arch AneurysmChronic Aortic Dissection

Keywords

Complex aortic repairAortic aneurysmAortic dissectionFenestrated/branched endograftCustom-made endovascular graft

Outcome Measures

Primary Outcomes (2)

  • Rate of treatment success

    Procedural treatment success is defined as successful access to the arterial system using remote arterial exposure, percutaneous technique or open surgical conduits. Success is also defined as successful delivery and deployment of the aortic graft and all stent components, side branch catheterization and placement of bridging stents and patency of all aortic modular stent graft components and intended side branch components.

    12 months

  • Rate of safety outcomes

    Safety outcomes is defined as freedom from major adverse events (all-cause mortality, myocardial infarction, disabling stroke, renal failure requiring new-onset dialysis, respiratory failure requiring prolonged (\>24hrs) mechanical ventilation or reintubation, paraplegia, bowel ischemia requiring surgical resection or not resolving with medical therapy)

    30 days

Interventions

Endovascular Aortic TreatmentsPROCEDURE

Use of Cook's custom-made endovascular grafts to treat complex abdominal, thoracoabdominal aortic diseases, or aortic arch diseases such as aneurysms and dissections.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients receiving a Cook custom made endovascular graft within the scope of the study in a maximum of 20 clinical sites in Europe.

You may qualify if:

  • \. Patients who will be treated with a Cook CMD

You may not qualify if:

  • Patients who declare they are unable to complete clinical follow-up visit at the time of enrollment, or
  • Patients or his/her legally authorized representative objects to extraction of patient's data from the medical record, or unwilling to sign the Informed Consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Hopital Marie Lannelongue

Le Plessis-Robinson, 92350, France

RECRUITING

CHU de Lille

Lille, 59037, France

RECRUITING

University Hospital Hamburg Eppendorf

Hamburg, 20251, Germany

RECRUITING

LMU Klinikum Munich

Munich, 80337, Germany

RECRUITING

St. Franzikus-Hospital Munster

Münster, 48145, Germany

RECRUITING

Klinnikum Nurnberg

Nuremberg, 90471, Germany

RECRUITING

PoliclinicoS Orsola Malpighi

Bologna, 40138, Italy

RECRUITING

Orsola Maplighi

Bologna, Italy

RECRUITING

Ospedal Policlinico San Martino-HSM

Genova, 16132, Italy

RECRUITING

IRCCS San Raffaele Hospital

Milan, 20132, Italy

RECRUITING

Skane University Hospital Malmo

Malmo, SE-205-02, Sweden

RECRUITING

Uppsala University Hospital

Uppsala, 75309, Sweden

RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B9 5SS, United Kingdom

RECRUITING

North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

RECRUITING

St Thomas' Hospital

London, SE1 9RT, United Kingdom

RECRUITING

St Barthowlomew's

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

Aortic Aneurysm, ThoracoabdominalAneurysm, Aortic ArchAortic AneurysmAortic Dissection

Condition Hierarchy (Ancestors)

Aortic Aneurysm, AbdominalAneurysmVascular DiseasesCardiovascular DiseasesAortic DiseasesAortic Aneurysm, ThoracicDissection, Blood VesselAcute Aortic Syndrome

Study Officials

  • Stephan Haulon, MD,PhD

    Hopital Marie Lannelongue

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gregoire Masliah

CONTACT

+41 795 490 954gregoie.masliah@cookmedical.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 31, 2023

First Posted

June 9, 2023

Study Start

May 31, 2023

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

December 1, 2030

Last Updated

July 8, 2025

Record last verified: 2025-07

Locations

DE(4)IT(4)FR(2)SE(2)DK(2)GB(4)