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Phase II Study of the Safety and Efficacy of the Relay Thoracic Stent-Graft

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ClinicalTrials.gov Identifier: NCT00435942
Recruitment Status : Completed
First Posted : February 16, 2007
Results First Posted : September 5, 2017
Last Update Posted : January 16, 2018
Sponsor:
Information provided by (Responsible Party):
Bolton Medical

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Thoracic Aortic Aneurysms
and Penetrating Atherosclerotic Ulcers
Interventions Device: Relay Thoracic Stent-Graft
Procedure: Open Repair
Enrollment 180
Recruitment Details Subjects screened and enrolled at 29 sites in the United States
Pre-assignment Details  
Arm/Group Title Relay Device Group Surgical Control Group
Hide Arm/Group Description Endovascular Treatment arm Open Surgical Repair arm
Period Title: Overall Study
Started 120 60
Completed [1] 97 33
Not Completed 23 27
Reason Not Completed
Death             17             10
Withdrawal by Subject             2             0
Lost to Follow-up             0             16
Conversion to Open Repair             1             0
Technical Failure             3             0
Other             0             1
[1]
97 patients
Arm/Group Title Relay Device Group Surgical Control Group Total
Hide Arm/Group Description Endovascular Treatment arm Open Surgical Repair arm Total of all reporting groups
Overall Number of Baseline Participants 120 60 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 60 participants 180 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
21
  17.5%
12
  20.0%
33
  18.3%
>=65 years
99
  82.5%
48
  80.0%
147
  81.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 120 participants 60 participants 180 participants
72.8  (11.02) 70.0  (9.17) 71.84  (10.39)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 120 participants 60 participants 180 participants
Female
58
  48.3%
20
  33.3%
78
  43.3%
Male
62
  51.7%
40
  66.7%
102
  56.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 120 participants 60 participants 180 participants
120 60 180
1.Primary Outcome
Title Primary Effectiveness Endpoint: Freedom From Major Adverse Device Effects
Hide Description

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.

Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All subjects who underwent the Relay implant procedure (Intention to Treat)
Arm/Group Title Relay Device Group
Hide Arm/Group Description:
Endovascular Treatment arm
Overall Number of Participants Analyzed 120
Measure Type: Number
Unit of Measure: participants
97
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Relay Device Group
Comments The proportion of subjects 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.
Type of Statistical Test Non-Inferiority or Equivalence
Comments The proportion of subjects 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.
Statistical Test of Hypothesis P-Value >0.80
Comments [Not Specified]
Method 1-sided z-test
Comments 97.5% 1-sided confidence interval
Method of Estimation Estimation Parameter Proportion free
Estimated Value 0.97
Confidence Interval (1-Sided) 97.5%
.93
Estimation Comments [Not Specified]
2.Primary Outcome
Title Primary Safety Endpoint: Distribution of Major Adverse Events
Hide Description 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
Time Frame 1 year
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The number of subjects who underwent the endovascular procedure or open surgical repair
Arm/Group Title Relay Device Group Surgical Control Group
Hide Arm/Group Description:
Endovascular Treatment arm
Open Surgical Repair arm
Overall Number of Participants Analyzed 120 60
Measure Type: Number
Unit of Measure: participants
27 51
Time Frame Adverse events were assessed for 1 year per participant, up to Day 673.
Adverse Event Reporting Description Adverse Events grouped by organ system
 
Arm/Group Title Relay Device Group Surgical Control Group
Hide Arm/Group Description Endovascular Treatment arm Open Surgical Repair arm
All-Cause Mortality
Relay Device Group Surgical Control Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Relay Device Group Surgical Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   68/120 (56.67%)      45/60 (75.00%)    
Blood and lymphatic system disorders     
Hematology complications  1 [1]  6/120 (5.00%)  10 3/60 (5.00%)  3
Cardiac disorders     
Cardiac complications  1  21/120 (17.50%)  32 12/60 (20.00%)  18
Gastrointestinal disorders     
Digestive/gastrointestinal complications  1  7/120 (5.83%)  7 8/60 (13.33%)  9
General disorders     
General  1 [2]  15/120 (12.50%)  19 7/60 (11.67%)  10
Injury, poisoning and procedural complications     
Bleeding events  1  12/120 (10.00%)  13 33/60 (55.00%)  37
Endoleak  1  4/120 (3.33%)  4 0/60 (0.00%)  0
Device malfunctions * 1  1/120 (0.83%)  1 1/60 (1.67%)  1
Trauma  1  1/120 (0.83%)  1 0/60 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm  1  4/120 (3.33%)  4 1/60 (1.67%)  1
Nervous system disorders     
Neurological complications  1 [3]  19/120 (15.83%)  22 8/60 (13.33%)  13
Renal and urinary disorders     
Renal/genitourinary complications  1  12/120 (10.00%)  15 6/60 (10.00%)  6
Respiratory, thoracic and mediastinal disorders     
Pulmonary Complications  1  20/120 (16.67%)  28 20/60 (33.33%)  27
Skin and subcutaneous tissue disorders     
Dermatological complications  1  1/120 (0.83%)  1 0/60 (0.00%)  0
Vascular disorders     
Vascular complications  1 [4]  10/120 (8.33%)  12 5/60 (8.33%)  6
Vascular access complications  1 [5]  4/120 (3.33%)  5 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, No source vocabulary
[1]
Includes anemia, coagulopathy, increased platelets
[2]
includes a variety of event types (e.g., decreased nutritional intake, volume overload, etc.)
[3]
Includes stroke, paraplegia, paraparesis
[4]
Includes ruptures of untreated aneurysms, aortic dissecton
[5]
includes access difficulty, iliac artery injury
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0.8%
Relay Device Group Surgical Control Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   97/120 (80.83%)      58/60 (96.67%)    
Blood and lymphatic system disorders     
Hematology complications  1 [1]  28/120 (23.33%)  58 19/60 (31.67%)  26
Cardiac disorders     
Cardiac complications  1  35/120 (29.17%)  56 27/60 (45.00%)  36
Gastrointestinal disorders     
Digestive/gastrointestinal complications  1  32/120 (26.67%)  51 14/60 (23.33%)  17
General disorders     
General  1  55/120 (45.83%)  127 31/60 (51.67%)  61
Hepatobiliary disorders     
Hepatic complications  1  2/120 (1.67%)  2 0/0  0
Injury, poisoning and procedural complications     
Bleeding Events  1 [2]  22/120 (18.33%)  26 25/60 (41.67%)  26
Endoleak  1  14/120 (11.67%)  16 0/60 (0.00%)  0
Device Malfunctions * 1  2/120 (1.67%)  5 0/60 (0.00%)  0
Trauma  1  0/120 (0.00%)  0 1/60 (1.67%)  1
Localized pain  1  23/120 (19.17%)  23 3/60 (5.00%)  3
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Neoplasm  1  1/120 (0.83%)  1 1/60 (1.67%)  1
Nervous system disorders     
Neurological complications  1  39/120 (32.50%)  53 20/60 (33.33%)  22
Renal and urinary disorders     
Renal/genitourinary complications  1  24/120 (20.00%)  36 9/60 (15.00%)  14
Respiratory, thoracic and mediastinal disorders     
Pulmonary complications  1  30/120 (25.00%)  50 35/60 (58.33%)  66
Skin and subcutaneous tissue disorders     
Dermatological Complications  1  21/120 (17.50%)  30 14/60 (23.33%)  20
Vascular disorders     
Vascular complications  1  9/120 (7.50%)  10 2/60 (3.33%)  2
Vascular Access Complications  1  10/120 (8.33%)  10 0/60 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, No source vocabulary
[1]
Includes anemia, coagulopathy, thrombocytopenia
[2]
Includes procedural bleeding and post-procedural bleeding
Many subjects experienced more than one type of event.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Investigator must provide Bolton Medical with the proposed publication for review. Bolton Medical had 30 days to review and had discretion to make changes.
Results Point of Contact
Name/Title: Annie Weiller
Organization: Bolton Medical, Inc.
Phone: 954-838-9699
Responsible Party: Bolton Medical
ClinicalTrials.gov Identifier: NCT00435942     History of Changes
Obsolete Identifiers: NCT00998491
Other Study ID Numbers: IP-0004-06
First Submitted: February 14, 2007
First Posted: February 16, 2007
Results First Submitted: September 23, 2013
Results First Posted: September 5, 2017
Last Update Posted: January 16, 2018