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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Aortic Dissection; Intramural Hematoma; Acute DeBakey I Dissection; Acute Type A Dissection
• Intervention / Treatment: Device: Ascyrus Medical Dissection Stent (AMDS)

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Emilie Chilaud; Phone Number: +33 672 415 101; Email: emilie.chilaud@artivion.com
• Study Contact Backup: Name: Svitlana Marchand; Phone Number: +33 685 365 793; Email: svitlana.marchand@artivion.com

Study Locations

• Germany
  • Berlin, Germany, 13353
    • Recruiting
    • Deutsches Herzzentrum der Charité
    • Contact: Jörg Kempfert, Prof.; Phone Number: 00 49 30 459 32 084; Email: joerg.kempfert@dhzc-charite.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients diagnosed with Acute DeBakey type I dissection based on CT angiography or IMH based on CT angiography and treated with the AMDS.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive arch remodeling	Rate of patients with positive arch remodeling defined as either stable or decreasing total aortic diameter in zone 2.	3-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause mortality	Rate of all-cause mortality	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	Discharge (definition: between 1-29 days)
Device-related mortality	Rate of device-related mortality	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	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	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	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	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	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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)	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	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	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	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	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)	Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)

Collaborators and Investigators

• Sponsor: JOTEC GmbH
• Investigators: Principal Investigator: Jörg Kempfert, Prof., German Heart Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2029

Study Registration Dates

• First Submitted: March 27, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 28, 2019

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular diseases; Malperfusion; Aortic diseases; Aortic Dissection; Aortic Remodeling; Acute Aortic Dissection
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hemorrhage; Aneurysm; Aortic Diseases; Dissection, Blood Vessel; Acute Aortic Syndrome; Hematoma; Aortic Dissection
• Other Study ID Numbers: PROTECT Registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All study participant data will be de-identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No