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

Primary Purpose

Aortic Dissection Type B, Intramural Hematoma, Penetrating Aortic Ulcer

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Cratos™ Stent Graft
Sponsored by
Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Aortic Dissection Type B

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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 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: 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 Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin Patient with a history of a hypercoagulability disorder and/or is currently in a hypercoagulability state Persistent refractory shock (systolic blood pressure <90 mm Hg) Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (ml/min/1.73 m2) or currently requiring dialysis Contraindications to antiplatelet drugs and anticoagulants Investigator judged that not suitable for interventional treatment.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    TEVAR

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    Mortality
    All-cause mortality

    Secondary Outcome Measures

    Full Information

    First Posted
    May 5, 2023
    Last Updated
    May 16, 2023
    Sponsor
    Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd
    Collaborators
    Qmed Consulting A/S
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05874206
    Brief Title
    CRATOS - Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
    Official Title
    Evaluation of Cratos™ Branch Stent Graft System in Treatment of Descending Aorta Lesions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    March 2031 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Shanghai MicroPort Endovascular MedTech(Group)Co., Ltd
    Collaborators
    Qmed Consulting A/S

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Aortic Dissection Type B, Intramural Hematoma, Penetrating Aortic Ulcer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    TEVAR
    Arm Type
    Experimental
    Arm Description
    Thoracic Endovascular Repair (TEVAR) provides a minimally invasive treatment option for descending thoracic aorta (DTA) pathologies.
    Intervention Type
    Device
    Intervention Name(s)
    Cratos™ Stent Graft
    Intervention Description
    Cratos™ Stent Graft TEVAR procedure for the treatment of aortic lesions.
    Primary Outcome Measure Information:
    Title
    Mortality
    Description
    All-cause mortality
    Time Frame
    30-day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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 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 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: 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 Previous instance of Heparin Induced Thrombocytopenia type 2 (HIT-2) or known hypersensitivity to heparin Patient with a history of a hypercoagulability disorder and/or is currently in a hypercoagulability state Persistent refractory shock (systolic blood pressure <90 mm Hg) Renal failure defined as patients with an estimated Glomerular Filtration Rate (eGFR) <30 (ml/min/1.73 m2) or currently requiring dialysis Contraindications to antiplatelet drugs and anticoagulants Investigator judged that not suitable for interventional treatment.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Jing Wang
    Phone
    +13105283618
    Email
    jing.wang@endovastec.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexander Zimmermann, Prof. Dr.
    Organizational Affiliation
    Universitätz Spital Zurich
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    IDP shared with trained, delegated and authorized site team members, independent DMC and CEC members.

    Learn more about this trial

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

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