Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection

N/AActive Not RecruitingNCT03894033

JOTEC GmbH301 enrolled

Overview

The objective of this registry is to collect information on the performance and clinical benefits of the AMDS (Ascyrus Medical Dissection Stent) to treat patients with acute "DeBakey type I dissections" and with or without so called "preoperative clinically relevant malperfusion" and/or "intramural hematomas". In a healthy aorta (the vessel that supplies blood to most of the body) the blood flows freely through the main lumen (a space inside the vessel where blood flows). The participants involved in this study have a tear that has separated the inner layer of the aorta wall and created a secondary channel (false lumen) in addition to the main channel (true lumen), and huts, the blood flows through both channels. AMDS is a stent (a metal tube helping to keep the vessel open) that is placed in the descending thoracic aorta. AMDS is a medical device commercially available in the countries in which the study is being conducted and it is used as standard of care according to its indication.

Observational, prospective and retrospective, non-randomized, non-interventional study to investigate the performance and clinical benefits of the AMDS to treat patients with acute DeBakey type I dissections with or without clinically relevant preoperative malperfusion and/or intramural hematomas (IMH). Participating physicians will be asked to provide their observations collected during routine care for patients they had decided to treat with AMDS. Informed consent of the patients to allow the use of their clinical records for the purpose of this observational study will be obtained before data are being collected. A total number of 300 subjects will be enrolled in up to 30 sites in Europe and Canada. The AMDS will be implanted according to the instructions for use and at the discretion of the treating physician. This registry was initiated by Ascyrus Medical GmbH in August 2019 (DARTS PM Registry). About 70 patients were enrolled at that time by German and Canadian sites under previous protocol. The patient's enrollment was put on-hold and the study has been re-started as PROTECT Registry with updated study documents as per JOTEC's standard operating procedures upon Ethics Committees approvals. Patients already included in DARTS PM Registry will be re-consented (where applicable as per local regulatory requirements) to allow the retrospective and prospective collection of additional data points not included in the initial version of the protocol. It is also planned to retrospectively include up to 150 subjects of the 300 targeted subjects, which have been treated with AMDS and who consent to the collection of their data (if required by national law) and are willing to continue in this registry, if applicable.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria * ≥18 and ≤ 80 years of age (male or female) * One of the following diagnosed within 14 days: * Acute DeBakey type I dissection based on CT angiography; or * IMH based on CT angiography Exclusion Criteria General Exclusion Criteria: * \< 18 years of age or \> 80 years of age (male or female) * Unwilling to comply with the follow-up schedule * Refusal to give Informed Consent Medical Exclusion Criteria: * Uncontrolled systemic infection * Uncontrollable anaphylaxis to iodinated contrast * Known allergy(ies) to nitinol and/ or PTFE * Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR) * Preoperative coma Anatomical Exclusion Criteria: * Any pathology of mycotic origin * Subacute or chronic dissection of the ascending aorta and aortic arch (\>14 days after the index event) * Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial) * Extensive thrombus or calcification in the aortic arch as defined by CT angiography * Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography

Outcomes

Primary Outcomes

Positive arch remodeling

Rate of patients with positive arch remodeling defined as either stable or decreasing total aortic diameter in zone 2.

Time frame: 3-6 months

Secondary Outcomes

All-cause mortality

Rate of all-cause mortality

Time frame: In-hospital, at 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years

Device-related in-hospital mortality

Rate of device-related in-hospital mortality

Time frame: Discharge (definition: between 1-29 days)

Device-related mortality

Rate of device-related mortality

Time frame: 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years

Resolution of malperfusion in patients who presented initially with malperfusion

Rate of patients with resolution of malperfusion in patients who presented initially with malperfusion

Time frame: Discharge (definition: between 1-29 days), 30 days, and 3-6 months

New disabling (Modified Rankin Scale mRS ≥ 2), permanent (>30 days) stroke

Rate of patients with new disabling (mRS ≥ 2), permanent (\>30 days) stroke

Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years

New disabling (Modified Rankin Scale mRS ≥ 2), transient (< 30 days) stroke

Rate of patients with new disabling (mRS ≥ 2), transient (\< 30 days) stroke

Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years

New paralysis

Rate of patients with new paralysis

Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years

New paraplegia

Rate of patients with new paraplegia and 5 years

Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years

New aortic rupture associated with the implantation of the device

Rate of patients with new aortic rupture associated with the implantation of the device (procedure or AMDS related)

Time frame: 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years

Patent innominate artery

Rate of patients with patent innominate artery (\< 50% stenosis of the origin of the branch vessels)

Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)

Source of innominate artery stenosis

Source of innominate artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

Patent left carotid artery

Rate of patients with patent left carotid artery (\< 50% stenosis of the origin of the branch vessels)

Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)

Source of left carotid artery stenosis

Source of left carotid artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)

Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)

Patent left subclavian artery

Rate of patients with patent left subclavian artery (\< 50% stenosis of the origin of the branch vessels)

Time frame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)

Source of left subclavian artery stenosis

Source of left subclavian artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

Absence of distal anastomotic new entry tear (DANE)

Rate of patients with absence of distal anastomotic new entry tear (DANE)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)

Increasing true lumen

Rate of patients with increasing true lumen \[change in diameter at the maximal diameter location within each Zone which is greater than or equal to a 5 mm expansion in comparison to the diameter on the pre-op computed tomography angiography (CTA) scan\] in the stented region (Zones 1-3)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)

Stable true lumen

Rate of patients with stable true lumen \[change in diameter at the maximal diameter location within each Zone which is between a 5 mm reduction and a 5 mm expansion in comparison to the diameter on the pre-op computed tomography angiography (CTA) scan\] in the stented region (Zones 1-3)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)

Stable or increasing true lumen in the stented region

Rate of patients with stable or increasing true lumen in the stented region (Zones 1-3)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

Decreasing true lumen

Rate of patients with decreasing true lumen \[change in diameter at the maximal diameter location within each Zone which is greater than or equal to a 5 mm reduction in comparison to the diameter on the pre-op computed tomography angiography (CTA) scan\] in the stented region (Zones 1-3)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

Increasing false lumen

Rate of patients with increasing false lumen (≥ 5mm) in the stented region (Zones 1-3)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

Stable false lumen in the stented region

Rate of patients with stable false lumen in the stented region (Zones 1-3)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

Decreasing false lumen

Rate of patients with decreasing false lumen (≤ - 5 mm) in the stented region (Zones 1-3)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

Rate of patients with stable or decreasing false lumen

Stable or decreasing false lumen in the stented region (Zones 1-3)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

Freedom from AMDS stent removal

Rate of patients with freedom from AMDS stent removal

Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years

Freedom from AMDS-related reintervention

Rate of patients with freedom from AMDS-related reintervention

Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years

Freedom from aortic arch reintervention

Rate of patients with freedom from aortic arch reintervention

Time frame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years

Successful AMDS deployment (at discharge

Rate of patients with successful AMDS deployment (at discharge

Time frame: Discharge (definition: between 1-29 days)

Completely thrombosed, partially thrombosed, or patent false lumen in the arch and descending aorta (Zones 0-5)

Rate of patients with completely thrombosed, partially thrombosed, or patent false lumen in the arch and descending aorta (Zones 0-5)

Time frame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes