Registry for the AMDS treatment of acute DeBakey type I aortic dissections
Official title: Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection: PROTECT Registry
Run by JOTEC GmbH · NCT03894033 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is collecting information on how well the Ascyrus Medical Dissection Stent works for patients with acute DeBakey type I aortic dissections to see if it helps improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | JOTEC GmbH Industry-sponsored |
| Locations | 1 site (Berlin) |
| Trial ID | NCT03894033 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this registry are adults aged 18 to 80 who have been diagnosed with acute DeBakey type I dissection or intramural hematoma within the last 14 days.
✕Probably not a fit
Patients with uncontrolled infections, severe allergies to necessary materials, or those in critical condition may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This registry aims to collect data on the performance and clinical benefits of the Ascyrus Medical Dissection Stent (AMDS) in treating patients with acute DeBakey type I aortic dissections, including those with preoperative malperfusion and intramural hematomas. The study is observational and will gather information from up to 300 patients across 30 sites in Europe and Canada. Physicians will document their observations during routine care, and informed consent will be obtained from patients for the use of their clinical records. The registry is a continuation of previous efforts to evaluate the AMDS and aims to enhance understanding of its effectiveness in clinical practice.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness of AMDS, potentially improving treatment outcomes for patients with acute aortic dissections.
How similar studies have gone: Other studies have shown promise in using similar stent technologies for aortic dissections, but this specific registry approach is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Deutsches Herzzentrum der Charité
Berlin, Germany Recruiting
Study contacts
- Principal investigator: Jörg Kempfert, Prof. — Deutsches Herzzentrum der Charité
- Study coordinator: Emilie Chilaud
- Email: emilie.chilaud@artivion.com
- Phone: +33 672 415 101
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Evaluation of the NEXUS Aortic Arch Stent Graft System for treating aortic conditions
This study is testing a new stent graft system to see if it can safely and effectively treat certain aortic problems in patients with specific conditions.
-
Endovascular repair for ascending aortic conditions
This study is testing if a special stent can safely repair problems in the ascending aorta for patients with conditions like aortic dissection and pseudoaneurysms.
-
Pregnancy-Related Aortic Dissection in China
This study looks at cases of aortic dissection that occur during pregnancy or shortly after, to understand outcomes for mothers and babies.
-
Ketorolac to improve outcomes and prognosis in Stanford Type A aortic dissection
This trial will test whether giving ketorolac around emergency surgery helps adults (18–65) with Stanford Type A aortic dissection recover better and have fewer complications over 90 days.
-
WeFlow-EndoPatch for Distal Aortic Tear Repair in Chronic Dissection
This study tests whether the WeFlow-EndoPatch Aortic Endovascular Patch can safely and effectively seal distal tears in chronic aortic dissection compared with standard treatment.
-
Aortic arch single-branch covered stent graft for treating aortic dissection
This trial tests a single-branch covered stent graft in adults with Stanford Type B aortic dissection who need revascularization of the left subclavian artery.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.