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

NCT ID: NCT05874206

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-08
• Study Completion Date: 2031-12-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TEVAR

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

Group Type: EXPERIMENTAL

Cratos™ Stent Graft

Intervention Type: DEVICE

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

Interventions

Cratos™ Stent Graft

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. 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

2. Age ≥18 years at time of informed consent signature

3. Informed Consent Form (ICF) is signed by Subject or legal representative

4. 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.

5. 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.

6. Must have appropriate distal aortic landing zone, defined as:

• Aortic inner diameters between 18-44 mm
• Landing zone cannot be heavily calcified, or heavily thrombosed.
• For isolated PAU, outer curvature length must be ≥ 2cm proximal to the celiac artery
• Landing zone in native aorta

Exclusion Criteria

1. Concomitant disease of the ascending aorta or aneurysm of the abdominal aorta requiring repair

2. Previous endovascular repair of the ascending aorta

3. Infected aorta, active systemic infection

4. Surgery within 30 days prior to enrolment with the exception of placement of vascular conduit for access .

5. Life expectancy <1 years

6. Myocardial infarction within 6 weeks prior to treatment

7. Stroke within 6 weeks prior to treatment.

8. Pregnant or breastfeeding female

9. 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.

10. Degenerative connective tissue disease, e.g., Marfan's or Ehlers-Danlos Syndrome

11. Participation in another drug or medical device study within one year of study enrolment

12. Known history of drug abuse within one year of treatment

13. Tortuous or stenotic iliac and/or femoral arteries preventing introducer sheath insertion and the inability to use a conduit for vascular access

14. Planned coverage of celiac artery

15. Allergic to contrast agents, anaesthetics and delivery materials

16. Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin

17. Patient with a history of a hypercoagulability disorder and/or is currently in a hypercoagulability state

18. Persistent refractory shock (systolic blood pressure <90 mm Hg)

19. Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (ml/min/1.73 m2) or currently requiring dialysis

20. Contraindications to antiplatelet drugs and anticoagulants

21. Investigator judged that not suitable for interventional treatment.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Qmed Consulting A/S

INDUSTRY

Sponsor Role: collaborator

Shanghai MicroPort Endovascular MedTech（Group）Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexander Zimmermann, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätz Spital Zurich

Locations

University Hospital Zurich

Zurich, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Jing Wang

Role: CONTACT

jing.wang@endovastec.com

3105283618

Facility Contacts

Alexander Zimmermann

Role: primary

gefaesschirurgie@usz.ch

+41 44 255 20 39

Other Identifiers

ENDO_E23-01

Identifier Type: -

Identifier Source: org_study_id