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| General |
| Study Status |
Completed |
Application Number /
Requirement Number |
P110038 / PAS001 |
| Date Original Protocol Accepted |
09/21/2012
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| Date Current Protocol Accepted |
02/06/2018
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| Study Name |
Relay Thoracic Stent-Graft w Plus Del Sys
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| Device Name |
RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Objective Performance Criterion
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
This is a multi-center observational prospective cohort study.
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| Study Population |
This population will consist of 120 Relay Phase II subjects and 13 Relay Continued Access study subjects plus 45 subjects treated post-approval with the Relay Thoracic Stent-Graft at centers which did not participate in the premarket studies.
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| Sample Size |
A sample size of 178 patients is based on the desire to have adequate follow up at 5-years to assess the primary endpoint assuming 20% attrition through thevfollow-up period. The sample size will include: 120 from Phase II study, 13 continued access subjects, and 45 subjects enrolled post-approval at a maximum of 30 sites which did not participate in the pre-marekt Relay studies, including Phase I feasiblity.
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| Key Study Endpoints |
The primary endpoint is measured as freedom from ARM at 5 years post- procedure. Aneurysm-related mortality is defined as death from rupture of the descending thoracic aortic aneurysm (DTAA) or penetrating aortic ulcer (PAU), or from any procedure intended to treat the DTAA or PAU. If a death occurred within 30 days of any procedure intended to treat the DTAA or PAU, or within the hospital stay if the patient was not discharged within 30 days, then it is presumed to be aneurysm-related.
Two secondary endpoints for this trial are the assessment of training effectiveness and the evaluation of major device-related events and major morbidity.
Training effectiveness will be assessed by comparing the following:
Delivery and deployment results of subjects treated by novice implanters of the Relay Thoracic Stent-Graft with Plus Delivery System (subjects enrolled in this study) to delivery and deployment results from the Relay Clinical Trial IP-0004-06
Survival, freedom from rupture, freedom from conversion, and number of endoleaks (Type I, III, and IV only) at 30 days post-implantation for the novice implanters’ first three implantations to those of the first three implantations of experienced implanters.
Major device-related events include the following: aneurysm rupture, increase in aneurysm sac size, conversion to open surgery, endoleak (Type I, III and IV only), stent migration (migration greater than or equal to 10 mm as compared to the 1-month visit), wireform fracture, and lumen occlusion.
Major morbidity is a composite of the following major adverse events. These events are considered by definition to be serious in nature.
Stroke (defined as a sudden, non-convulsive loss of neurological function due to an ischemic or hemorrhagic intracranial vascular event);
Paralysis / Paraplegia (defined as loss of power or voluntary movement in a muscle through injury to or disease of its nerve supply within 30 days of the procedure. Paraplegia is paralysis of both lower extremities, and generally lower trunk, within 30 days of the procedure);
Myocardial Infarction (defined as an acute episode in which circulation to a region of the heart is obstructed and necrosis is occurring; it is usually characterized by severe pain, frequently associated with pallor, perspiration, nausea, dyspnea, and dizziness; electrographic abnormalities may include Q wave ST segment, and T wave alterations);
Respiratory Failure (defined as a need for mechanical ventilation beyond the first 48 hours after the procedure or the need for reintubation or ventilator support any time between 48 hours and 30 days postoperative);
Renal Failure (defined as rise in creatinine greater than 50% above the pre- procedure level resulting in a creatinine level above high normal that does not spontaneously resolve and requires dialysis treatment); and
All-Cause Mortality.
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| Follow-up Visits and Length of Follow-up |
5 years
1 month, 1 year, and annually thereafter
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| Interim or Final Data Summary |
| Actual Number of Patients Enrolled |
45 subjects
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| Actual Number of Sites Enrolled |
23 sites were initiated in the study
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| Patient Follow-up Rate |
Clinical Follow-up rates:
30 day: 42/45 (93.3%)
1-year: 36/42 (85.8%)
2-year: 29/36 (80.6%)
3-year: 25/29 (86.2%)
4-year: 21/26 (80.8%)
5-year: 13/19 (68.4%)
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| Final Safety Findings |
Death
Twelve (12) subjects have expired.
Aneurysm-Related Mortality
Two (2) deaths were categorized as aneurysm-related mortality. The deaths occurred within 30 days of the initial procedure.
Rupture
There have been no treated aneursym ruptures.
Major Adverse Events
A total of four (4) subjects have experienced MAEs; events for two (2) of the subjects occurring within 2 days of the implant procedure. One (1) subject experienced a bilateral hemispheric stroke on the date of the procedure, and another (1) subject developed respiratory failure and paraplegia following the procedure. One (1) subject experienced a stroke at 128 days post implant, but subsequently recovered one day later following hospitalization and medical management. One (1) subject reported myocardial infarction at 1 year.
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| Final Effect Findings |
Conversions to Open Surgery
There have been no conversions to open repair
Secondary Interventions
There was one (1) secondary intervention at 1 year post-implant due to possible Type III endoleak. The subject was treated with an additional RelayPlus.
Endoleaks
Core Lab analysis of imaging data confirmed one (1) Type Ib endoleak and one (1) Type Ia endoleak at 3 years and one (1) Type III endoleak at 4 years. Interventions were not performed on the Type I endoleaks due to the investigators not agreeing with the findings. There were no Type IV endoleaks.
Device Integrity
There were no reports of device integrity events.
Aneurysm Sac Enlargement ( > 5 mm)
Two (2) subjects had onset of aneurysm sac increase of > 5mm at 1 year. One (1) subject with sac enlargement at 3 years. In total, three subjects experienced aneurysm sac enlargement.
Patency
There were no losses of patency in any subject through any follow-up visit.
Migration
Two (2) events of migration were reported by the Core Lab; however, for one (1) of these, the repositioning is thought to be likely related to aortic lengthening and not true distal migration.
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| Study Strengths & Weaknesses |
Strengths: This was a multi-center prospective cohort study that enrolled sites and subjects that did not participate in the Relay Pivotal Study. Core Lab analyzed the imaging, and an independent clinical events committee adjudicated event relatedness to the procedure, technique, and/or device.
Weaknesses: Due to difficulties with enrollment, the enrollment in the de novo cohort was capped at 45 subjects rather than the originally agreed upon target of 100 subjects. Therefore, the originally planned statistical analysis as defined in the original protocol could not be performed. As such, the results were presented in descriptive statistics. The study is a non-randomized study with inherent biases. The study had high attrition; only 19 of 45 initial subjects were eligible for the 5-year visit, of which 13 subjects completed the 5-year visit.
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| Recommendations for Labeling Changes |
Labeling Supplement will not be recommended. However, the team will recommend to the sponsor to provide a labeling update to point to the Clinical Update for updated results on the study
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