Trial Outcomes & Findings for DURABILITY™ Iliac Study (NCT NCT01400919)
NCT ID: NCT01400919
Last Updated: 2018-03-07
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
75 participants
Primary outcome timeframe
9 months
Results posted on
2018-03-07
Participant Flow
Participant milestones
| Measure |
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Overall Study
STARTED
|
75
|
|
Overall Study
COMPLETED
|
67
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Missed visit
|
2
|
Baseline Characteristics
DURABILITY™ Iliac Study
Baseline characteristics by cohort
| Measure |
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
n=75 Participants
The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 8.9 • n=99 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
n=75 Participants
The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Major Adverse Event Rate
|
1.3 percentage of participants
|
Adverse Events
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
Serious events: 29 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
n=75 participants at risk
The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Cardiac disorders
Cardiac disorders
|
8.0%
6/75 • Number of events 9 • All events that occured within 9 months
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
2.7%
2/75 • Number of events 2 • All events that occured within 9 months
|
|
General disorders
General disorders and administration site conditions
|
1.3%
1/75 • Number of events 1 • All events that occured within 9 months
|
|
Infections and infestations
Infections and infestations
|
4.0%
3/75 • Number of events 3 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
9.3%
7/75 • Number of events 7 • All events that occured within 9 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
5.3%
4/75 • Number of events 4 • All events that occured within 9 months
|
|
Nervous system disorders
Nervous system disorders
|
4.0%
3/75 • Number of events 3 • All events that occured within 9 months
|
|
Vascular disorders
Vascular disorders
|
16.0%
12/75 • Number of events 18 • All events that occured within 9 months
|
Other adverse events
| Measure |
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
n=75 participants at risk
The objective of the study is to confirm the safety and effectiveness of the Protégé EverFlex and Protégé GPS Self-Expanding Stent Systems in the treatment of stenotic, restenotic or occluded lesions in the common and external iliac artery.
Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.: Implantation of one or more study devices in the common and/or external iliac artery.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
17.3%
13/75 • Number of events 18 • All events that occured within 9 months
|
|
General disorders
General disorders and administration site conditions
|
18.7%
14/75 • Number of events 15 • All events that occured within 9 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications
|
14.7%
11/75 • Number of events 15 • All events that occured within 9 months
|
|
Vascular disorders
Vascular disorders
|
10.7%
8/75 • Number of events 8 • All events that occured within 9 months
|
|
Respiratory, thoracic and mediastinal disorders
espiratory, thoracic and mediastinal disorders
|
8.0%
6/75 • Number of events 6 • All events that occured within 9 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
5.3%
4/75 • Number of events 5 • All events that occured within 9 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
5.3%
4/75 • Number of events 4 • All events that occured within 9 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There IS an agreement between the Principal Investigator and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results without permission of the sponsor. Trial is still ongoing
- Publication restrictions are in place
Restriction type: OTHER