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

Recruiting
Conditions
Aortic Dissection
Intramural Hematoma
Acute DeBakey I Dissection
Acute Type A Dissection
Registration Number
NCT03894033
Lead Sponsor
JOTEC GmbH
Brief Summary

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.

Detailed Description

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.

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
300
Inclusion Criteria

Not provided

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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Positive arch remodeling3-6 months

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

Secondary Outcome Measures
NameTimeMethod
Device-related in-hospital mortalityDischarge (definition: between 1-29 days)

Rate of device-related in-hospital mortality

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

Rate of patients with new paraplegia and 5 years

Resolution of malperfusion in patients who presented initially with malperfusionDischarge (definition: between 1-29 days), 30 days, and 3-6 months

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

Patent left carotid arteryDischarge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)

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

All-cause mortalityIn-hospital, at 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years

Rate of all-cause mortality

New disabling (Modified Rankin Scale mRS ≥ 2), permanent (>30 days) strokeDischarge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years

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

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

Rate of patients with new paralysis

New aortic rupture associated with the implantation of the device30 days, 3-6 months,1 year, 2, 3, 4 and 5 years

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

Source of left carotid artery stenosisDischarge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)

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

Patent left subclavian arteryDischarge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)

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

Device-related mortality30 days, 3-6 months, 1 year, 2, 3, 4, 5 years

Rate of device-related mortality

New disabling (Modified Rankin Scale mRS ≥ 2), transient (< 30 days) strokeDischarge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years

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

Patent innominate arteryDischarge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)

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

Source of innominate artery stenosisDischarge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

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

Stable or increasing true lumen in the stented regionDischarge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

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

Increasing false lumenDischarge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

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

Freedom from AMDS-related reinterventionDischarge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years

Rate of patients with freedom from AMDS-related reintervention

Decreasing false lumenDischarge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

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

Rate of patients with stable or decreasing false lumenDischarge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

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

Source of left subclavian artery stenosisDischarge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

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

Absence of distal anastomotic new entry tear (DANE)Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)

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

Increasing true lumenDischarge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)

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)

Decreasing true lumenDischarge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

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)

Stable false lumen in the stented regionDischarge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

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

Freedom from AMDS stent removalDischarge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years

Rate of patients with freedom from AMDS stent removal

Freedom from aortic arch reinterventionDischarge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years

Rate of patients with freedom from aortic arch reintervention

Successful AMDS deployment (at dischargeDischarge (definition: between 1-29 days)

Rate of patients with successful AMDS deployment (at discharge

Completely thrombosed, partially thrombosed, or patent false lumen in the arch and descending aorta (Zones 0-5)Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

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

Stable true lumenDischarge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)

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)

Trial Locations

Locations (1)

Deutsches Herzzentrum der Charité

🇩🇪

Berlin, Germany

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