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

Aortic Dissection Clinical Trial

— PROTECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03894033
• Other study ID #: PROTECT Registry
• Status: Recruiting
• Start date: March 12, 2019
• Est. completion date: June 30, 2029

Study information

• Verified date: January 2024
• Source: JOTEC GmbH
• Contact: Emilie Chilaud
• Phone: +33 672 415 101
• Email: emilie.chilaud[@]artivion.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2029
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute DeBakey I Dissection
• Acute Type A Dissection
• Aortic Dissection
• Hematoma
• Intramural Hematoma

Intervention

Device:
• Ascyrus Medical Dissection Stent (AMDS)
The device will be implanted during already planned surgical intervention for aortic dissection repair. The participant will be observed and data gathered during the surgery and routine standard of care follow up visits.

Locations

Country	Name	City	State
Germany	Deutsches Herzzentrum der Charité	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
JOTEC GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	All-cause mortality	Rate of all-cause mortality	In-hospital, at 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years
Secondary	Device-related in-hospital mortality	Rate of device-related in-hospital mortality	Discharge (definition: between 1-29 days)
Secondary	Device-related mortality	Rate of device-related mortality	30 days, 3-6 months, 1 year, 2, 3, 4, 5 years
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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
Secondary	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
Secondary	Successful AMDS deployment (at discharge	Rate of patients with successful AMDS deployment (at discharge	Discharge (definition: between 1-29 days)
Secondary	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)