Post-market Registry of the AMDS for the Treatment of Acute DeBakey Type I Dissection: PROTECT Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- JOTEC GmbH
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Positive arch remodeling
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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
排除标准
- •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
结局指标
主要结局
Positive arch remodeling
时间窗: 3-6 months
Rate of patients with positive arch remodeling defined as either stable or decreasing total aortic diameter in zone 2.
次要结局
- Device-related in-hospital mortality(Discharge (definition: between 1-29 days))
- New paraplegia(Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years)
- Resolution of malperfusion in patients who presented initially with malperfusion(Discharge (definition: between 1-29 days), 30 days, and 3-6 months)
- Patent left carotid artery(Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab))
- All-cause mortality(In-hospital, at 30 days, 3-6 months, 1 year, 2, 3, 4, 5 years)
- 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)
- New paralysis(Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years)
- New aortic rupture associated with the implantation of the device(30 days, 3-6 months,1 year, 2, 3, 4 and 5 years)
- Source of left carotid artery stenosis(Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab))
- Patent left subclavian artery(Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab))
- Device-related mortality(30 days, 3-6 months, 1 year, 2, 3, 4, 5 years)
- New disabling (Modified Rankin Scale mRS ≥ 2), transient (< 30 days) stroke(Discharge (definition: between 1-29 days), 30 days, 3-6 months,1 year, 2, 3, 4 and 5 years)
- Patent innominate artery(Discharge (definition: between 1-29 days), 3-6 months,1 year, 2, 3, 4 and 5 years (CoreLab))
- Source of innominate artery stenosis(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab))
- Stable or increasing true lumen in the stented region(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab))
- Increasing false lumen(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab))
- Freedom from AMDS-related reintervention(Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years)
- Decreasing false lumen(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab))
- Rate of patients with stable or decreasing false lumen(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab))
- Source of left subclavian artery stenosis(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab))
- Absence of distal anastomotic new entry tear (DANE)(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab))
- Increasing true lumen(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab))
- Decreasing true lumen(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab))
- Stable false lumen in the stented region(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab))
- Freedom from AMDS stent removal(Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years)
- Freedom from aortic arch reintervention(Discharge (definition: between 1-29 days), 30 days, 3-6 months, 1 year, 2, 3, 4 and 5 years)
- Successful AMDS deployment (at discharge(Discharge (definition: between 1-29 days))
- Completely thrombosed, partially thrombosed, or patent false lumen in the arch and descending aorta (Zones 0-5)(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4 and 5 years (CoreLab))
- Stable true lumen(Discharge (definition: between 1-29 days), 3-6 months, 1 year, 2, 3, 4, and 5 years (CoreLab))