Clinical trial NCT03894033: Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection
Official title: Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection: PROTECT Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Dissection
Acute DeBakey I Dissection
Acute Type A Dissection
Intramural Hematoma
Keywords: Aortic diseases
Cardiovascular diseases
Aortic Dissection
Aortic Remodeling
Malperfusion
Acute Aortic Dissection
Lead sponsor: JOTEC GmbH
Sponsor class: INDUSTRY
First posted: 2019-03-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive arch remodeling
timeFrame: 3-6 months
Secondary outcomes:
measure: All-cause mortality
timeFrame: In-hospital, at 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years
measure: Device-related in-hospital mortality
timeFrame: Discharge (definition: between 1-29 days)
measure: Device-related mortality
timeFrame: 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years
measure: Resolution of malperfusion in patients who presented initially with malperfusion
timeFrame: Discharge (definition: between 1-29 days), 30 days, and 3-6 months
measure: New disabling (Modified Rankin Scale mRS ≥ 2), permanent (>30 days) stroke
timeFrame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
measure: New disabling (Modified Rankin Scale mRS ≥ 2), transient (< 30 days) stroke
timeFrame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
measure: New paralysis
timeFrame: Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
measure: New paraplegia
timeFrame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
measure: New aortic rupture associated with the implantation of the device
timeFrame: 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years
measure: Patent innominate artery
timeFrame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Source of innominate artery stenosis
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Patent left carotid artery
timeFrame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Source of left carotid artery stenosis
timeFrame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Patent left subclavian artery
timeFrame: Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Source of left subclavian artery stenosis
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Absence of distal anastomotic new entry tear (DANE)
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
measure: Increasing true lumen
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
measure: Stable true lumen
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)
measure: Stable or increasing true lumen in the stented region
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Decreasing true lumen
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Increasing false lumen
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Stable false lumen in the stented region
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Decreasing false lumen
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Rate of patients with stable or decreasing false lumen
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
measure: Freedom from AMDS stent removal
timeFrame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
measure: Freedom from AMDS-related reintervention
timeFrame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
measure: Freedom from aortic arch reintervention
timeFrame: Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years
measure: Successful AMDS deployment (at discharge
timeFrame: Discharge (definition: between 1-29 days)
measure: Completely thrombosed, partially thrombosed, or patent false lumen in the arch and descending aorta (Zones 0-5)
timeFrame: Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Deutsches Herzzentrum der Charité
Study officials:
affiliation: Deutsches Herzzentrum der Charité
name: Jörg Kempfert, Prof.
role: PRINCIPAL_INVESTIGATOR
References: