Registry for the AMDS treatment of acute DeBakey type I aortic dissections
Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection: PROTECT Registry
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | JOTEC GmbH Industry-sponsored |
| Locations | 1 site (Berlin) |
| Trial ID | NCT03894033 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with uncontrolled infections, severe allergies to necessary materials, or those in critical condition may not benefit from this study.
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 performed: Other studies have shown promise in using similar stent technologies for aortic dissections, but this specific registry approach is relatively novel.
Eligibility criteria
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 this trial is running
Berlin
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.