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Post-Approval Clinical Study of the Talent Thoracic Stent Graft to Treat Thoracic Aortic Aneurysms (THRIVE) (THRIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00805948
Recruitment Status : Terminated (Study device discontinued & insufficient sample size for statistical results.)
First Posted : December 10, 2008
Results First Posted : August 14, 2019
Last Update Posted : August 14, 2019
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Thoracic Aortic Aneurysms
Intervention Device: Talent Thoracic Stent Graft System
Enrollment 349
Recruitment Details  
Pre-assignment Details  
Arm/Group Title De Novo Group Valor Test Group
Hide Arm/Group Description 154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device. 195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
Period Title: Overall Study
Started 154 195
Completed 86 99
Not Completed 68 96
Arm/Group Title De Novo Group Valor Test Group Total
Hide Arm/Group Description 154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device. 195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol. Total of all reporting groups
Overall Number of Baseline Participants 154 195 349
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 154 participants 195 participants 349 participants
71.1  (11.4) 70.2  (11.1) 70.6  (11.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 195 participants 349 participants
Female
74
  48.1%
80
  41.0%
154
  44.1%
Male
80
  51.9%
115
  59.0%
195
  55.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 195 participants 349 participants
Hispanic or Latino
7
   4.5%
5
   2.6%
12
   3.4%
Not Hispanic or Latino
145
  94.2%
190
  97.4%
335
  96.0%
Unknown or Not Reported
2
   1.3%
0
   0.0%
2
   0.6%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 154 participants 195 participants 349 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian/Native Hawaiian or Pacific Islander
4
   2.6%
2
   1.0%
6
   1.7%
Black or African American
20
  13.0%
25
  12.8%
45
  12.9%
White
127
  82.5%
162
  83.1%
289
  82.8%
Other
3
   1.9%
1
   0.5%
4
   1.1%
Unknown or Not Available
0
   0.0%
5
   2.6%
5
   1.4%
1.Primary Outcome
Title Freedom From Aneurysm-related Mortality at 5 Years
Hide Description For all THRIVE subjects, Aneurysm-Related Mortality (ARM) is defined as: Death from rupture of the thoracic aortic aneurysm or from any procedure intended to treat the Descending Thoracic Aneurysm (DTA - fusiform aneurysms and saccular aneurysms/penetrating ulcers) as determined by an independent Clinical Events Committee (CEC). If a death occurred within 30 days of any procedure intended to treat the DTA, then it is presumed to be aneurysm related, unless there is evidence to the contrary.
Time Frame 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All participants were combined for analysis as a single arm, as pre-specified in the protocol. Subjects are censored because their last follow-up has not reached the end of the time interval or because they withdraw, are lost to follow-up or die from a non-aneurysm related cause.
Arm/Group Title All Subjects
Hide Arm/Group Description:
All Subjects (349) is comprised of 195 subjects from the VALOR Test Group (PMA P070007) and 154 of the planned 256 De Novo subjects.
Overall Number of Participants Analyzed 349
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
92
(88 to 95)
2.Other Pre-specified Outcome
Title All-Cause Mortality
Hide Description Number of subjects who died during that interval or who were followed at least until the lower endpoint of the analysis window.
Time Frame 1, 12, 24, 36, 48 and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on all Intent to Treat (ITT) subjects.
Arm/Group Title De Novo Group Valor Test Group
Hide Arm/Group Description:
154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.
195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
Overall Number of Participants Analyzed 154 195
Measure Type: Number
Unit of Measure: Participants
0-30 days 5 4
0 - 365 days 17 31
366 - 731 days 18 11
732 - 1096 days 8 15
1097 - 1461 days 8 9
1462 - 1826 days 3 10
3.Other Pre-specified Outcome
Title Number of Participants With Conversion to Surgery
Hide Description Conversion from endovascular to open repair required at the time of the original procedure or at the time beyond the initial endovascular procedure (for the same lesion treated during the initial implantation of the Talent Thoracic Stent Graft)
Time Frame 1, 12, 24, 36, 48 and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on all Intent to Treat (ITT) subjects.
Arm/Group Title De Novo Group Valor Test Group
Hide Arm/Group Description:
154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.
195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
Overall Number of Participants Analyzed 154 195
Measure Type: Number
Unit of Measure: participants
0-30 days 1 0
0-365 days 2 1
366-731 days 0 1
732-1096 days 0 1
1097-1461 days 0 0
1462-1826 days 0 1
4.Other Pre-specified Outcome
Title Number of Participants With Aneurysm Rupture
Hide Description Rupture or perforation of the targeted aneurismal sac as detected by angiography, CT scan, or direct observation at surgery or autopsy.
Time Frame 1, 12, 24, 36, 48 and 60 months
Hide Outcome Measure Data
Hide Analysis Population Description
Based on all Intent to Treat (ITT) subjects
Arm/Group Title De Novo Group Valor Test Group
Hide Arm/Group Description:
154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device.
195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
Overall Number of Participants Analyzed 154 195
Measure Type: Number
Unit of Measure: participants
0-30 days 0 0
0-365 days 0 1
366-731 days 2 0
732-1096 days 1 2
1097-1461 days 0 0
1462-1826 days 0 2
Time Frame 5 years
Adverse Event Reporting Description

The 195 VALOR subjects completed follow-up on 16-Jun-2011 per VALOR protocol PMA P070007 (previously reported via G980116/S280). Due to limited access to this older study data, the AE terms couldn't be re-validated using MedDRA. Therefore, the AE terms of Valor subjects are posted as they were originally validated, using the Valor study-specific definitions.

The 154 De Novo subjects were followed per the THRIVE protocol. The AE terms for De Novo subjects were validated using MedDRA 17.0.

 
Arm/Group Title De Novo Group Valor Test Group
Hide Arm/Group Description 154 of the planned 256 prospectively enrolled De Novo subjects treated with the Talent Thoracic Stent Graft System following U.S. market approval of the device. 195 subjects from the Valor Test Group (PMA P070007) that were followed for 5 years per the VALOR protocol.
All-Cause Mortality
De Novo Group Valor Test Group
Affected / at Risk (%) Affected / at Risk (%)
Total   54/154 (35.06%)      76/195 (38.97%)    
Hide Serious Adverse Events
De Novo Group Valor Test Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   83/154 (53.90%)      178/195 (91.28%)    
Blood and lymphatic system disorders     
Other-Enlarged Lymph Nodes - Right * 2  0/0  0 1/195 (0.51%)  1
Cardiac disorders     
Aortic Valve Disease * 1  1/154 (0.65%)  1 0/0  0
Arrhythmia * 1  1/154 (0.65%)  1 0/0  0
Cardiac Arrest * 1  5/154 (3.25%)  5 0/0  0
Cardiac Failure * 1  1/154 (0.65%)  1 0/0  0
Cardiac Failure Congestive * 1  1/154 (0.65%)  1 0/0  0
Cardiogenic Shock * 1  1/154 (0.65%)  1 0/0  0
Cardiopulmonary Failure * 1  2/154 (1.30%)  2 0/0  0
Ischaemic Cardiomyopathy * 1  1/154 (0.65%)  1 0/0  0
Myocardial Infarction * 1  4/154 (2.60%)  4 0/0  0
Cardiac and hemodynamic (general) * 2  0/0  0 50/195 (25.64%)  64
Cardiac Arrhythmia * 2  0/0  0 16/195 (8.21%)  17
Congestive heart failure * 2  0/0  0 18/195 (9.23%)  23
Myocardial infarction * 2  0/0  0 12/195 (6.15%)  13
Congenital, familial and genetic disorders     
Other - (L) Hip Dysplasia * 2  0/0  0 1/195 (0.51%)  1
Gastrointestinal disorders     
Gastrointestinal Haemorrhage * 1  2/154 (1.30%)  2 0/0  0
Gastrooesophageal Reflux Disease * 1  1/154 (0.65%)  1 0/0  0
Intestinal Ischaemia * 1  2/154 (1.30%)  2 0/0  0
Retroperitoneal Haemorrhage * 1  2/154 (1.30%)  2 0/0  0
Umbilical Hernia * 1  1/154 (0.65%)  1 0/0  0
Gastrointestinal (general) * 2  0/0  0 32/195 (16.41%)  44
Bowel obstruction * 2  0/0  0 3/195 (1.54%)  3
Mesenteric ischemia * 2  0/0  0 3/195 (1.54%)  3
GI bleed * 2  0/0  0 12/195 (6.15%)  18
General disorders     
Device Dislocation * 1  1/154 (0.65%)  1 0/0  0
Multi-Organ Failure * 1  1/154 (0.65%)  1 0/0  0
Stent-Graft Endoleak * 1  20/154 (12.99%)  23 0/0  0
Arterial insertion trauma * 2  0/0  0 10/195 (5.13%)  10
Graft endoleak * 2  0/0  0 29/195 (14.87%)  36
Graft migration * 2  0/0  0 2/195 (1.03%)  2
Other - Hernia * 2  0/0  0 2/195 (1.03%)  2
Other - Weakness * 2  0/0  0 1/195 (0.51%)  1
Other - Fever * 2  0/0  0 4/195 (2.05%)  4
Other - Pain * 2  0/0  0 5/195 (2.56%)  5
Other - Pain * 2 [1]  0/0  0 1/195 (0.51%)  1
Hepatobiliary disorders     
Other - Cirrhosis * 2  0/0  0 1/195 (0.51%)  1
Infections and infestations     
Clostridium Difficile Colitis * 1  1/154 (0.65%)  1 0/0  0
Groin Infection * 1  1/154 (0.65%)  1 0/0  0
Infection * 1  1/154 (0.65%)  1 0/0  0
Infective Aneurysm * 1  1/154 (0.65%)  1 0/0  0
Pneumonia * 1  3/154 (1.95%)  4 0/0  0
Sepsis * 1  6/154 (3.90%)  6 0/0  0
Wound Infection * 1  1/154 (0.65%)  1 0/0  0
Infection * 2  0/0  0 22/195 (11.28%)  28
Other - Fever * 2 [2]  0/0  0 1/195 (0.51%)  1
Injury, poisoning and procedural complications     
Procedural Haemorrhage * 1  9/154 (5.84%)  9 0/0  0
Vascular Pseudoaneurysm * 1  1/154 (0.65%)  2 0/0  0
Wound * 1  1/154 (0.65%)  1 0/0  0
Other - (R) Hip Fracture * 2  0/0  0 1/195 (0.51%)  1
Other - Acute Morphine Poisoning * 2  0/0  0 1/195 (0.51%)  1
Other - Cervical Spine Fracture * 2  0/0  0 1/195 (0.51%)  1
Other - Fall - FX Hip * 2  0/0  0 1/195 (0.51%)  1
Other - Fracture of Left Leg * 2  0/0  0 1/195 (0.51%)  1
Other - Fractured Left Foot * 2  0/0  0 1/195 (0.51%)  1
Other - Hip Fracture * 2  0/0  0 1/195 (0.51%)  1
Other - Right Femur Fracture * 2  0/0  0 1/195 (0.51%)  1
Other - Splenic Rupture * 2  0/0  0 1/195 (0.51%)  1
Metabolism and nutrition disorders     
Other - Hypercalcemia * 2  0/0  0 1/195 (0.51%)  1
Other - Hypoalbuminemia/Malnutrition * 2  0/0  0 1/195 (0.51%)  1
Other - Malnutrition * 2  0/0  0 2/195 (1.03%)  2
Musculoskeletal and connective tissue disorders     
Compartment Syndrome * 1  1/154 (0.65%)  1 0/0  0
Other - Arthritis of Knee * 2  0/0  0 1/195 (0.51%)  1
Other - Broken Hip * 2  0/0  0 1/195 (0.51%)  1
Other - Degenerative Joint Disease * 2  0/0  0 1/195 (0.51%)  1
Other - Osteoarthritis (L) Knee * 2  0/0  0 1/195 (0.51%)  1
Other - Osteoarthritis/(L) Total Knee * 2  0/0  0 1/195 (0.51%)  1
Other - Back Pain * 2  0/0  0 4/195 (2.05%)  5
Other - Pain * 2 [3]  0/0  0 1/195 (0.51%)  1
Other - Pain * 2 [4]  0/0  0 1/195 (0.51%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Bladder Cancer * 1  1/154 (0.65%)  1 0/0  0
Metastases To Bone * 1  1/154 (0.65%)  1 0/0  0
Neoplasm Malignant * 1  1/154 (0.65%)  1 0/0  0
Oesophageal Carcinoma * 1  1/154 (0.65%)  1 0/0  0
Prostate Cancer Metastatic * 1  1/154 (0.65%)  1 0/0  0
Cancer * 2  0/0  0 18/195 (9.23%)  21
Nervous system disorders     
Cerebral Haemorrhage * 1  3/154 (1.95%)  3 0/0  0
Cerebrovascular Accident * 1  7/154 (4.55%)  8 0/0  0
Paraparesis * 1  2/154 (1.30%)  2 0/0  0
Neurologic (general) * 2  0/0  0 20/195 (10.26%)  22
Paraplegia and paraparesis * 2  0/0  0 13/195 (6.67%)  13
Stroke * 2  0/0  0 14/195 (7.18%)  15
Transient Ischemic Attack (TIA) * 2  0/0  0 3/195 (1.54%)  3
Other - Dizziness * 2  0/0  0 1/195 (0.51%)  1
Psychiatric disorders     
Mental Status Changes * 1  3/154 (1.95%)  3 0/0  0
Other - Auditory and Visual * 2  0/0  0 1/195 (0.51%)  1
Other - Suicidal Ideation * 2  0/0  0 1/195 (0.51%)  1
Other - Anxiety * 2  0/0  0 1/195 (0.51%)  1
Renal and urinary disorders     
Renal Failure * 1  11/154 (7.14%)  13 0/0  0
Renal Failure Acute * 1  2/154 (1.30%)  2 0/0  0
Renal complications (general) * 2  0/0  0 17/195 (8.72%)  22
Urologic * 2  0/0  0 8/195 (4.10%)  8
Reproductive system and breast disorders     
Other - Uterine Prolapse * 2  0/0  0 1/195 (0.51%)  1
Respiratory, thoracic and mediastinal disorders     
Acute Respiratory Distress Syndrome * 1  2/154 (1.30%)  2 0/0  0
Acute Respiratory Failure * 1  3/154 (1.95%)  3 0/0  0
Atelectasis * 1  2/154 (1.30%)  2 0/0  0
Chronic Obstructive Pulmonary Disease * 1  3/154 (1.95%)  3 0/0  0
Diaphragmatic Paralysis * 1  1/154 (0.65%)  1 0/0  0
Haemoptysis * 1  1/154 (0.65%)  1 0/0  0
Lung Disorder * 1  1/154 (0.65%)  1 0/0  0
Pleural Effusion * 1  1/154 (0.65%)  1 0/0  0
Respiratory Failure * 1  18/154 (11.69%)  18 0/0  0
Pulmonary complications (general) * 2  0/0  0 61/195 (31.28%)  98
Surgical and medical procedures     
Coronary Artery Bypass * 1  1/154 (0.65%)  1 0/0  0
Other - (L) Knee Replacement * 2  0/0  0 1/195 (0.51%)  1
Other - Immature Fistula, Permacath * 2  0/0  0 1/195 (0.51%)  1
Vascular disorders     
Aneurysm * 1  3/154 (1.95%)  3 0/0  0
Aneurysm Ruptured * 1  1/154 (0.65%)  1 0/0  0
Aortic Aneurysm * 1  3/154 (1.95%)  3 0/0  0
Aortic Aneurysm Rupture * 1  1/154 (0.65%)  1 0/0  0
Aortic Dilatation * 1  1/154 (0.65%)  1 0/0  0
Aortic Dissection * 1  1/154 (0.65%)  1 0/0  0
Aortic Rupture * 1  4/154 (2.60%)  4 0/0  0
Arterial Occlusive Disease * 1  1/154 (0.65%)  1 0/0  0
Arteriosclerosis * 1  1/154 (0.65%)  1 0/0  0
Deep Vein Thrombosis * 1  1/154 (0.65%)  1 0/0  0
Embolism * 1  1/154 (0.65%)  1 0/0  0
Peripheral Artery Dissection * 1  4/154 (2.60%)  4 0/0  0
Peripheral Ischaemia * 1  1/154 (0.65%)  1 0/0  0
Bleeding and hematogenic * 2  0/0  0 69/195 (35.38%)  92
Arterial * 2  0/0  0 50/195 (25.64%)  65
Arterial embolism * 2  0/0  0 8/195 (4.10%)  9
TAA rupture * 2  0/0  0 5/195 (2.56%)  5
Venous * 2  0/0  0 3/195 (1.54%)  3
1
Term from vocabulary, MedDRA (17.0)
2
Term from vocabulary, Study specific
*
Indicates events were collected by non-systematic assessment
[1]
Right groin
[2]
Fungemia
[3]
Left side of neck, left arm and leg
[4]
(L) calf pain
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
De Novo Group Valor Test Group
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/154 (0.00%)      0/195 (0.00%)    
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Michael McGuffey, Clinical Research Director
Organization: Medtronic, Inc
Phone: 707-591-7126
EMail: michael.mcguffey@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT00805948    
Other Study ID Numbers: Investigational Plan #109
First Submitted: December 8, 2008
First Posted: December 10, 2008
Results First Submitted: September 19, 2017
Results First Posted: August 14, 2019
Last Update Posted: August 14, 2019