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

NCT03894033 | Active Not Recruiting DMC

• 1 other identifier: PROTECT Registry
• Study Type: observational
• Target: 301
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (29)

• All-cause mortality

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

• Device-related in-hospital mortality

  Discharge (definition: between 1-29 days)

• 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

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

• New disabling (Modified Rankin Scale 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

Interventions

Ascyrus Medical Dissection Stent (AMDS) DEVICE

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.

Also known as: AMDS Arch Remodeling Therapy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• ≥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

You may not qualify if:

• \< 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
• 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
• 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

Sponsors & Collaborators

• JOTEC GmbH: lead

Study Sites (1)

Deutsches Herzzentrum der Charité

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Aortic Dissection; Aortic Diseases; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Dissection, Blood Vessel; Aneurysm; Vascular Diseases; Acute Aortic Syndrome

Study Officials

• Jörg Kempfert, Prof.

  Deutsches Herzzentrum der Charité

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2019
• First Posted: March 28, 2019
• Study Start: March 12, 2019
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)