Aortic Aneurysm, Thoracic, Penetrating Ulcer
Conditions
Brief summary
Investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms (TAA) and penetrating atherosclerotic ulcers (PAU) of the descending thoracic aorta.
Detailed description
The objective of this study is to investigate the safety and effectiveness of the RelayPro Thoracic Stent-Grafts in subjects with thoracic aortic aneurysms and penetrating atherosclerotic ulcers of the descending thoracic aorta.
Interventions
DEVICERelayPro
Endovascular treatment with investigational device.
Sponsors
Bolton Medical
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be ≥ 18 years of age * Subject has specified disease in his/her descending thoracic aorta. * Subject have anatomical compliance for the device specified for both access vessels and treatment area. * Subject must be willing to comply with the follow-up evaluation schedule. * Subject (or Legally Authorized Representative) agrees an Informed Consent Form prior to treatment.
Exclusion criteria
* Subject has specified disease of the thoracic aorta which is not included in the trial, for example: aortic dissection, intramural hematoma, traumatic injury or transection, aortic false aneurysm, ruptured aneurysm. * Subject anatomy with significant stenosis, calcification, thrombus or tortuosity. * Subjects with specified compromised circulation. * Subjects with specified prior procedures. * Subjects with allergy to contrast media or device components. * Subjects with disease, for example: suspected connective tissue disorder, specified coagulation disorders, specified coronary artery disease, severe congestive heart failure, stroke and/or Myocardial Infarction (MI) as specified, specified pulmonary disease, specified renal failure. * Subjects that are pregnant or planning to become pregnant during the course of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Major Adverse Events (MAEs) | 30 days | Primary safety endpoint is a composite of the following MAEs occurring through 30 days: * Death * Stroke (excluding transient ischemic attack) * Paralysis (excludes paraparesis) |
| Technical success | 24 hours | Primary effectiveness rate as measured by the technical success through 24 hours, defined as: * Successful delivery of the device through the vasculature; * Successful deployment of the device at the intended location; Absence of Type I or III endoleaks; Patent stent-graft without significant stenosis. |
| Stent graft patency | 12 months | Primary effectiveness as measured by the rate of stent-graft patency through 12 months. |
| Aneurysm rupture | 12 months | Primary effectiveness as measured by the absence of aneurysm rupture through 12 months. |
| Absence of Type I and III endoleak through 12 months; | 12 months | Primary effectiveness as measured by the absence of Type I and III endoleak through 12 months. |
| Absence of stent fractures in the attachment zone through 12 months | 12 months | Primary effectiveness as measured by the absence of stent fractures in the attachment zone through 12 months. |
| Absence of open or endovascular secondary interventions | 12 months | Primary effectiveness as measured by the absence of open or endovascular secondary interventions related to the device or treated pathology through 12 months. |
| Absence of aneurysm expansion (> 5 mm diameter increase) | 12 months | Primary effectiveness as measured by the absence of aneurysm expansion (\> 5 mm diameter increase) through 12 months, compared to the first post-procedural computed tomographic (CT) imaging study. |
| Absence of stent-graft migration | 12 months | Primary effectiveness as measured by the absence of stent-graft migration (\> 10 mm) through 12 months, compared to the first post-procedural CT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of implant procedure | Treatment Visit | Duration of the initial implant procedure captured as the number of minutes from introduction of device to removal of delivery system. |
| Number of blood transfusions | Treatment Visit through Discharge Visit | Number of transfusions (units) required from the time of implant through hospital discharge. |
| Loss of stent-graft patency | 1 month and 6 months | Loss of stent-graft patency will be assessed with CT scans, or MRIs for subjects unable to tolerate contrast media. |
| Time in Intensive Care Unit (ICU) | Treatment Visit through Discharge Visit | Duration of time in hours that subject was admitted to the Intensive Care Unit (ICU) following the implant procedure. |
| Duration of hospitalization | Treatment Visit through Discharge Visit | Length of hospital stay defined as number of days subject was hospitalized for the initial implant procedure. |
| Rate of aneurysm rupture | 1 month and 6 months | The rate of aneurysm rupture through 1 month and 6 months will be assessed by review of CT or MRI imaging, in addition to site reported adverse events. |
| Rate of endoleaks of all types | 1 month, 6 months and 12 months | Persistence of blood flow outside the lumen of the stent-graft but within the native aorta or adjacent vascular segment being treated by the stent-graft will be assessed by CT scans or MRIs for subjects unable to tolerate contrast media. |
| Rate of stent fractures in the attachment zone | 1 month and 6 months | Stent fractures in the attachment zone will be assessed at each follow-up visit with CT scans, or MRIs for subjects unable to tolerate contrast media. |
| Incidence of open or endovascular secondary interventions | 1 month and 6 months | Secondary effectiveness will be measured by the incidence of open or endovascular secondary interventions related to the device or treated pathology (ie, interventions to treat malperfusion, rupture, aneurysm formation, or aortic expansion). |
| Rate of aneurysm expansion | 1 month and 6 months | The rate of aneurysm expansion (\> 5 mm diameter increase) assessed by comparison of follow-up imaging to the first post-procedural CT |
| Rate of stent-graft migration | 1 month and 6 months | The rate of stent-graft migration (\> 10 mm) assessed by comparison of follow-up imaging to the first post-procedural CT. |
| Individual outcomes of composite MAEs | 6 months and 12 months | Secondary effectiveness as measured by the individual outcomes of the composite safety endpoints (death, stroke, paralysis), as well as myocardial infarction (MI), renal failure, respiratory failure, bowel ischemia, and procedural blood loss \>1,000 cc. |
| Rate of vascular access complications | During the initial implant attempt | Secondary effectiveness as measured by the rate of vascular access complications reported during the Treatment visit (stent-graft implant). Outcome measures include successful delivery and deployment of the device, as well as withdrawal of the delivery system. |
Countries
Japan, United States
Outcome results
None listed