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

NCT05874206 | Recruiting DMC

• 1 other identifier: ENDO_E23-01
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Mortality

  All-cause mortality

  30-day

Study Arms (1)

TEVAR

EXPERIMENTAL

Thoracic Endovascular Repair (TEVAR) provides a minimally invasive treatment option for descending thoracic aorta (DTA) pathologies.

Device: Cratos™ Stent Graft

Interventions

Cratos™ Stent Graft DEVICE

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

TEVAR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of thoracic aortic pathology (Dissection, including IMH and ULP; and PAU) deemed to warrant surgical repair which requires proximal graft placement in Zone 2
• Age ≥18 years at time of informed consent signature
• Informed Consent Form (ICF) is signed by Subject or legal representative
• Must have appropriate proximal aortic landing zone, defined as:
• Landing zone inner diameters between 23-41 mm
• The length of landing zone ≥15mm
• Landing without heavily calcified or heavily thrombosed
• Dissection Patients: Primary entry tear must be distal to LSA, and proximal extent of the proximal landing zone must not be dissected.
• For patients with prior replacement of the ascending aorta and/or aortic arch by a surgical graft, there must be at least 2 cm of landing zone proximal to the most distal anastomosis site.
• Must have appropriate LSA landing zone, defined as:
• Inner diameters of LSA 5-14 mm
• Minimum length of Left subclavian artery is 25 mm
• Target branch vessel landing zone must be in native aorta that cannot be severely tortuous , aneurysmal, dissected, heavily calcified, or heavily thrombosed.
• Must have appropriate distal aortic landing zone, defined as:
• Aortic inner diameters between 18-44 mm

You may not qualify if:

• Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair
• Previous endovascular repair of the ascending aorta
• Infected aorta, active systemic infection
• Surgery within 30 days prior to enrolment with the exception of placement of vascular conduit for access .
• Life expectancy \<1 years
• Myocardial infarction within 6 weeks prior to treatment
• Stroke within 6 weeks prior to treatment.
• Pregnant or breastfeeding female
• Patient has an active systemic infection (e.g., infection requiring treatment with parenteral anti-infective medication) that may place the patient at increased risk of endovascular infection.
• Degenerative connective tissue disease, e.g., Marfan's or Ehlers-Danlos Syndrome
• Participation in another drug or medical device study within one year of study enrolment
• Known history of drug abuse within one year of treatment
• Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access
• Planned coverage of celiac artery
• Allergic to contrast agents, anaesthetics and delivery materials

Sponsors & Collaborators

• Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd: lead
• Qmed Consulting A/S: collaborator

Study Sites (1)

University Hospital Zurich

Zurich, Switzerland

RECRUITING

MeSH Terms

Conditions

Penetrating Atherosclerotic Ulcer

Condition Hierarchy (Ancestors)

Acute Aortic Syndrome; Aortic Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Alexander Zimmermann, Prof. Dr.

  Universitätz Spital Zurich

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Wang

CONTACT

3105283618; jing.wang@endovastec.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 24, 2023
• Study Start: March 8, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2031
• Last Updated: February 26, 2025

Record last verified: 2024-09

Locations

CH (1)