CratosTM Thoracic Branch Stent Graft System is used for the treatment of aortic lesions including aortic dissection, Intramural Hematoma and Penetrating Atherosclerotic Ulcer.

• Conditions: Acute Complicated Type B Aortic Dissection; 10002363

• Registration Number: NL-OMON56955
• Lead Sponsor: Shanghai MicroPort Endovascular MedTech (Group) Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 12

Inclusion Criteria

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 18-41 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 (Note: Bare stent or graft stent implanted
during the procedure before investigational device implantation is allowed)
Note: In Switzerland, Informed Consent can only be signed by subject
Cohort 1 Acute Complicated Type B Aortic dissection (including ULP type) / IMH
Cohort
Patients must meet both of the following:
1. Dissection is acute time from symptom onset to dissection diagnosis <=14 days.
2. Must present with at least one of the following:
- Presence of aortic rupture (either free or contained (including hemothorax,
increasing periaortic hematoma, or both; or mediastinal hematoma)
- Branch artery occlusion and malperfusion (complete or partial occlusion of a
major branch, with or without clinical evidence of ischemia; this includes
visceral, renal, and peripheral arterial branches)
- Extension of dissection flap either distally or proximally
- Aortic enlargement: Progressive enlargement of the true, false, or both lumens
- Intractable pain
- Uncontrolled hypertension
IMH patients must meet both of the following:
1. IMH is acute time from symptom onset to IMH diagnosis <=14 days.
2. Must present with at least one of the following:
- Malperfusion
- Periaortic hematoma
- Pericardial effusion with cardiac tamponade
- Persistent, refractory, or recurrent pain
- Rupture
Cohort 2 Non-acute complicated type B Dissection (including ULP type) / IMH and
Penetrating aortic ulcer Cohort
Non-acute complicated type B dissection (including ULP type) patients must meet
one of the following criteria:
- Presented with high-risk imaging findings. High-risk imaging findings include
Maximum aortic diameter > 40mm, False-lumen diameter >20mm, Entry Tear > 10mm;
Entry tear on lesser curvature; Increase in total aortic diameter of > 5 mm
between serial imaging studies, Bloody pleural effusion. Presented with
high-risk imaging features of IMH in uncomplicated type B

Exclusion Criteria

1. Concomitant disease of the ascending aorta or aneurysm of the abdominal
aorta requiring repair
2. Aortic lesion resulting from Traumatic Transection
3. Previous endovascular repair of the ascending aorta
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 infected aorta and/or 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, anesthetics stent graft materials 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. Patients aren*t willing to or lacking capacity in the informed consent
procedure
22. Investigator judged that not suitable for interventional treatment.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>30-day all-cause Mortality rate (Cohort 1: Acute Complicated Type B Aortic<br /><br>Dissection)</p><br>