Trial Outcomes & Findings for Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft (NCT NCT00435942)
NCT ID: NCT00435942
Last Updated: 2018-01-16
Results Overview
The primary effectiveness endpoint was freedom from major device-related adverse events \[endoleak (Types I, III and IV), stent migration (\> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair\] at 1 year post-procedure. The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
180 participants
Primary outcome timeframe
1 year
Results posted on
2018-01-16
Participant Flow
Subjects screened and enrolled at 29 sites in the United States
Participant milestones
| Measure |
Relay Device Group
Endovascular Treatment arm
|
Surgical Control Group
Open Surgical Repair arm
|
|---|---|---|
|
Overall Study
STARTED
|
120
|
60
|
|
Overall Study
COMPLETED
|
97
|
33
|
|
Overall Study
NOT COMPLETED
|
23
|
27
|
Reasons for withdrawal
| Measure |
Relay Device Group
Endovascular Treatment arm
|
Surgical Control Group
Open Surgical Repair arm
|
|---|---|---|
|
Overall Study
Death
|
17
|
10
|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
16
|
|
Overall Study
Conversion to Open Repair
|
1
|
0
|
|
Overall Study
Technical Failure
|
3
|
0
|
|
Overall Study
Other
|
0
|
1
|
Baseline Characteristics
Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft
Baseline characteristics by cohort
| Measure |
Relay Device Group
n=120 Participants
Endovascular Treatment arm
|
Surgical Control Group
n=60 Participants
Open Surgical Repair arm
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
21 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
99 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
147 Participants
n=5 Participants
|
|
Age, Continuous
|
72.8 years
STANDARD_DEVIATION 11.02 • n=5 Participants
|
70.0 years
STANDARD_DEVIATION 9.17 • n=7 Participants
|
71.84 years
STANDARD_DEVIATION 10.39 • n=5 Participants
|
|
Sex: Female, Male
Female
|
58 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
120 participants
n=5 Participants
|
60 participants
n=7 Participants
|
180 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All subjects who underwent the Relay implant procedure (Intention to Treat)
The primary effectiveness endpoint was freedom from major device-related adverse events \[endoleak (Types I, III and IV), stent migration (\> 10mm as compared to the 1 month visit), lumen occlusion, aneurysm rupture, and deployment failure/conversion to surgical repair\] at 1 year post-procedure. The proportion of participants in the Effectiveness sample who were free from major device-related AEs at 1-year post-procedure was compared against a performance goal of 0.80 using a 1-sided z-test (normal approximation to the binomial) at an alpha level of 0.025. Rejection of the null hypothesis would provide evidence that this performance goal (proportion-free greater than 0.80) was met.
Outcome measures
| Measure |
Relay Device Group
n=120 Participants
Endovascular Treatment arm
|
Surgical Control Group
Open Surgical Repair arm
|
|---|---|---|
|
Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects
|
97 participants
|
—
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The number of subjects who underwent the endovascular procedure or open surgical repair
The primary safety endpoint was the distribution of participants experiencing at least 1 of the major adverse events (aneurysm-related mortality, stroke, paralysis/paraplegia, myocardial infarction, procedural bleeding, respiratory failure, renal failure, and wound healing complications) within 1 year post-procedure
Outcome measures
| Measure |
Relay Device Group
n=120 Participants
Endovascular Treatment arm
|
Surgical Control Group
n=60 Participants
Open Surgical Repair arm
|
|---|---|---|
|
Primary Safety Endpoint: Distribution of Major Adverse Events
|
27 participants
|
51 participants
|
Adverse Events
Relay Device Group
Serious events: 68 serious events
Other events: 97 other events
Deaths: 0 deaths
Surgical Control Group
Serious events: 45 serious events
Other events: 58 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Relay Device Group
n=120 participants at risk
Endovascular Treatment arm
|
Surgical Control Group
n=60 participants at risk
Open Surgical Repair arm
|
|---|---|---|
|
Gastrointestinal disorders
Digestive/gastrointestinal complications
|
5.8%
7/120 • Number of events 7 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
13.3%
8/60 • Number of events 9 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Skin and subcutaneous tissue disorders
Dermatological complications
|
0.83%
1/120 • Number of events 1 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
0.00%
0/60 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Injury, poisoning and procedural complications
Device malfunctions
|
0.83%
1/120 • Number of events 1 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
1.7%
1/60 • Number of events 1 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Injury, poisoning and procedural complications
Trauma
|
0.83%
1/120 • Number of events 1 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
0.00%
0/60 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Injury, poisoning and procedural complications
Bleeding events
|
10.0%
12/120 • Number of events 13 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
55.0%
33/60 • Number of events 37 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Cardiac disorders
Cardiac complications
|
17.5%
21/120 • Number of events 32 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
20.0%
12/60 • Number of events 18 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Injury, poisoning and procedural complications
Endoleak
|
3.3%
4/120 • Number of events 4 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
0.00%
0/60 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Blood and lymphatic system disorders
Hematology complications
|
5.0%
6/120 • Number of events 10 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
5.0%
3/60 • Number of events 3 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Nervous system disorders
Neurological complications
|
15.8%
19/120 • Number of events 22 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
13.3%
8/60 • Number of events 13 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Complications
|
16.7%
20/120 • Number of events 28 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
33.3%
20/60 • Number of events 27 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Renal and urinary disorders
Renal/genitourinary complications
|
10.0%
12/120 • Number of events 15 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
10.0%
6/60 • Number of events 6 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Vascular disorders
Vascular complications
|
8.3%
10/120 • Number of events 12 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
8.3%
5/60 • Number of events 6 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Vascular disorders
Vascular access complications
|
3.3%
4/120 • Number of events 5 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
0.00%
0/60 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
General disorders
General
|
12.5%
15/120 • Number of events 19 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
11.7%
7/60 • Number of events 10 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
3.3%
4/120 • Number of events 4 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
1.7%
1/60 • Number of events 1 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
Other adverse events
| Measure |
Relay Device Group
n=120 participants at risk
Endovascular Treatment arm
|
Surgical Control Group
n=60 participants at risk
Open Surgical Repair arm
|
|---|---|---|
|
Injury, poisoning and procedural complications
Bleeding Events
|
18.3%
22/120 • Number of events 26 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
41.7%
25/60 • Number of events 26 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Cardiac disorders
Cardiac complications
|
29.2%
35/120 • Number of events 56 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
45.0%
27/60 • Number of events 36 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Injury, poisoning and procedural complications
Endoleak
|
11.7%
14/120 • Number of events 16 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
0.00%
0/60 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Blood and lymphatic system disorders
Hematology complications
|
23.3%
28/120 • Number of events 58 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
31.7%
19/60 • Number of events 26 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Nervous system disorders
Neurological complications
|
32.5%
39/120 • Number of events 53 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
33.3%
20/60 • Number of events 22 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary complications
|
25.0%
30/120 • Number of events 50 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
58.3%
35/60 • Number of events 66 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Renal and urinary disorders
Renal/genitourinary complications
|
20.0%
24/120 • Number of events 36 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
15.0%
9/60 • Number of events 14 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Vascular disorders
Vascular complications
|
7.5%
9/120 • Number of events 10 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
3.3%
2/60 • Number of events 2 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Vascular disorders
Vascular Access Complications
|
8.3%
10/120 • Number of events 10 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
0.00%
0/60 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
General disorders
General
|
45.8%
55/120 • Number of events 127 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
51.7%
31/60 • Number of events 61 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm
|
0.83%
1/120 • Number of events 1 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
1.7%
1/60 • Number of events 1 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Gastrointestinal disorders
Digestive/gastrointestinal complications
|
26.7%
32/120 • Number of events 51 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
23.3%
14/60 • Number of events 17 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Skin and subcutaneous tissue disorders
Dermatological Complications
|
17.5%
21/120 • Number of events 30 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
23.3%
14/60 • Number of events 20 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Injury, poisoning and procedural complications
Device Malfunctions
|
1.7%
2/120 • Number of events 5 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
0.00%
0/60 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Injury, poisoning and procedural complications
Trauma
|
0.00%
0/120 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
1.7%
1/60 • Number of events 1 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Injury, poisoning and procedural complications
Localized pain
|
19.2%
23/120 • Number of events 23 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
5.0%
3/60 • Number of events 3 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
|
Hepatobiliary disorders
Hepatic complications
|
1.7%
2/120 • Number of events 2 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
—
0/0 • Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Events grouped by organ system
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator must provide Bolton Medical with the proposed publication for review. Bolton Medical had 30 days to review and had discretion to make changes.
- Publication restrictions are in place
Restriction type: OTHER