Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2026-01-06 @ 3:06 PM
Study NCT ID:
NCT03894033
Status:
RECRUITING
Last Update Posted:
2025-05-02
First Post:
2019-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000784', 'term': 'Aortic Dissection'}, {'id': 'D001018', 'term': 'Aortic Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D000094665', 'term': 'Dissection, Blood Vessel'}, {'id': 'D000783', 'term': 'Aneurysm'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D000094683', 'term': 'Acute Aortic Syndrome'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2019-03-27', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2025-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive arch remodeling', 'timeFrame': '3-6 months', 'description': 'Rate of patients with positive arch remodeling defined as either stable or decreasing total aortic diameter in zone 2.'}], 'secondaryOutcomes': [{'measure': 'All-cause mortality', 'timeFrame': 'In-hospital, at 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years', 'description': 'Rate of all-cause mortality'}, {'measure': 'Device-related in-hospital mortality', 'timeFrame': 'Discharge (definition: between 1-29 days)', 'description': 'Rate of device-related in-hospital mortality'}, {'measure': 'Device-related mortality', 'timeFrame': '30 days, 3-6 months, 1 year, 2, 3, 4, 5 years', 'description': 'Rate of device-related mortality'}, {'measure': 'Resolution of malperfusion in patients who presented initially with malperfusion', 'timeFrame': 'Discharge (definition: between 1-29 days), 30 days, and 3-6 months', 'description': 'Rate of patients with resolution of malperfusion in patients who presented initially with malperfusion'}, {'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', 'description': 'Rate of patients with new disabling (mRS ≥ 2), permanent (\\>30 days) stroke'}, {'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', 'description': 'Rate of patients with new disabling (mRS ≥ 2), transient (\\< 30 days) stroke'}, {'measure': 'New paralysis', 'timeFrame': 'Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years', 'description': 'Rate of patients with new paralysis'}, {'measure': 'New paraplegia', 'timeFrame': 'Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years', 'description': 'Rate of patients with new paraplegia 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', 'description': 'Rate of patients with new aortic rupture associated with the implantation of the device (procedure or AMDS related)'}, {'measure': 'Patent innominate artery', 'timeFrame': 'Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)', 'description': 'Rate of patients with patent innominate artery (\\< 50% stenosis of the origin of the branch vessels)'}, {'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)', 'description': 'Source of innominate artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)'}, {'measure': 'Patent left carotid artery', 'timeFrame': 'Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)', 'description': 'Rate of patients with patent left carotid artery (\\< 50% stenosis of the origin of the branch vessels)'}, {'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)', 'description': 'Source of left carotid artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)'}, {'measure': 'Patent left subclavian artery', 'timeFrame': 'Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab)', 'description': 'Rate of patients with patent left subclavian artery (\\< 50% stenosis of the origin of the branch vessels)'}, {'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)', 'description': 'Source of left subclavian artery stenosis (thrombosis, dissection flap covering, dissection extension into vessel)'}, {'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)', 'description': 'Rate of patients with absence of distal anastomotic new entry tear (DANE)'}, {'measure': 'Increasing true lumen', 'timeFrame': 'Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)', 'description': '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)'}, {'measure': 'Stable true lumen', 'timeFrame': 'Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab)', 'description': '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)'}, {'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)', 'description': 'Rate of patients with stable or increasing true lumen in the stented region (Zones 1-3)'}, {'measure': 'Decreasing true lumen', 'timeFrame': 'Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)', 'description': '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)'}, {'measure': 'Increasing false lumen', 'timeFrame': 'Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)', 'description': 'Rate of patients with increasing false lumen (≥ 5mm) in the stented region (Zones 1-3)'}, {'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)', 'description': 'Rate of patients with stable false lumen in the stented region (Zones 1-3)'}, {'measure': 'Decreasing false lumen', 'timeFrame': 'Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab)', 'description': 'Rate of patients with decreasing false lumen (≤ - 5 mm) in the stented region (Zones 1-3)'}, {'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)', 'description': 'Stable or decreasing false lumen in the stented region (Zones 1-3)'}, {'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', 'description': 'Rate of patients with freedom from AMDS stent removal'}, {'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', 'description': 'Rate of patients with freedom from AMDS-related reintervention'}, {'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', 'description': 'Rate of patients with freedom from aortic arch reintervention'}, {'measure': 'Successful AMDS deployment (at discharge', 'timeFrame': 'Discharge (definition: between 1-29 days)', 'description': 'Rate of patients with successful AMDS deployment (at discharge'}, {'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)', 'description': 'Rate of patients with completely thrombosed, partially thrombosed, or patent false lumen in the arch and descending aorta (Zones 0-5)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Aortic diseases', 'Cardiovascular diseases', 'Aortic Dissection', 'Aortic Remodeling', 'Malperfusion', 'Acute Aortic Dissection'], 'conditions': ['Aortic Dissection', 'Acute DeBakey I Dissection', 'Acute Type A Dissection', 'Intramural Hematoma']}, 'descriptionModule': {'briefSummary': '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".\n\nIn 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.\n\nAMDS 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.', 'detailedDescription': "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).\n\nParticipating 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.\n\nA 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.\n\nThis 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.\n\nPatients 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients diagnosed with Acute DeBakey type I dissection based on CT angiography or IMH based on CT angiography and treated with the AMDS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* ≥18 and ≤ 80 years of age (male or female)\n* One of the following diagnosed within 14 days:\n\n * Acute DeBakey type I dissection based on CT angiography; or\n * IMH based on CT angiography\n\nExclusion Criteria\n\nGeneral Exclusion Criteria:\n\n* \\< 18 years of age or \\> 80 years of age (male or female)\n* Unwilling to comply with the follow-up schedule\n* Refusal to give Informed Consent\n\nMedical Exclusion Criteria:\n\n* Uncontrolled systemic infection\n* Uncontrollable anaphylaxis to iodinated contrast\n* Known allergy(ies) to nitinol and/ or PTFE\n* Patient in extreme hemodynamic compromise requiring cardiopulmonary resuscitation (CPR)\n* Preoperative coma\n\nAnatomical Exclusion Criteria:\n\n* Any pathology of mycotic origin\n* Subacute or chronic dissection of the ascending aorta and aortic arch (\\>14 days after the index event)\n* Aortic fistulous communication with non-vascular structure (e.g. esophagus, bronchial)\n* Extensive thrombus or calcification in the aortic arch as defined by CT angiography\n* Excessive tortuosity precluding safe passage of the AMDS as defined by CT angiography'}, 'identificationModule': {'nctId': 'NCT03894033', 'acronym': 'PROTECT', 'briefTitle': 'Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection', 'organization': {'class': 'INDUSTRY', 'fullName': 'JOTEC GmbH'}, 'officialTitle': 'Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection: PROTECT Registry', 'orgStudyIdInfo': {'id': 'PROTECT Registry'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ascyrus Medical Dissection Stent (AMDS)', 'type': 'DEVICE', 'otherNames': ['AMDS Arch Remodeling Therapy'], 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '13353', 'city': 'Berlin', 'state': 'State of Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jörg Kempfert, Prof.', 'role': 'CONTACT', 'email': 'joerg.kempfert@dhzc-charite.de', 'phone': '00 49 30 459 32 084'}], 'facility': 'Deutsches Herzzentrum der Charité', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'centralContacts': [{'name': 'Emilie Chilaud', 'role': 'CONTACT', 'email': 'emilie.chilaud@artivion.com', 'phone': '+33 672 415 101'}, {'name': 'Svitlana Marchand', 'role': 'CONTACT', 'email': 'svitlana.marchand@artivion.com', 'phone': '+33 685 365 793'}], 'overallOfficials': [{'name': 'Jörg Kempfert, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Deutsches Herzzentrum der Charité'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'All study participant data will be de-identified.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'JOTEC GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}