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CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions

NCT05874206 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2025-02-26

No results posted yet for this study

Summary

The goal of this prospective, interventional, multicentre, single-arm performance objective study is to evaluate efficacy and safety of Cratos™ Branch Stent Graft System in treatment of lesions (dissection, IMH and PAU in descending aorta. The main question\[s\] it aims to answer are:

* 30-day all-cause Mortality rate
* Composite of the following events from the time of enrolment through 12-month:

* Device Technical Success
* Absence of: Aortic rupture, Lesion-related mortality, Disabling Stroke, Permanent paraplegia, Permanent paraparesis, New onset renal failure requiring permanent dialysis, Additional unanticipated post-procedural surgical or interventional procedure related to the device, procedure, or withdrawal of the device system

Participants will come for hospital office visits 1, 6, 12, 24-, 36-, 48- and 60-months post-procedure for the following, but not limited to assessments:

* Physical examination
* Modified Rankin scale
* Tarlov scoring scale
* CTA

Conditions

  • Aortic Dissection Type B
  • Intramural Hematoma
  • Penetrating Aortic Ulcer

Interventions

DEVICE

Cratos™ Stent Graft

Cratos™ Stent Graft TEVAR procedure for the treatment of aortic lesions.

Sponsors & Collaborators

  • Qmed Consulting A/S

    collaborator INDUSTRY

  • Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

    lead INDUSTRY

Principal Investigators

  • Alexander Zimmermann, Prof. Dr. · Universitätz Spital Zurich

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-08
Primary Completion
2026-12-31
Completion
2031-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05874206 on ClinicalTrials.gov