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DURABILITY™ Iliac Study

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: NCT01400919
Recruitment Status : Completed
First Posted : July 25, 2011
Results First Posted : June 24, 2015
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Medtronic Endovascular

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Peripheral Arterial Disease
Claudication
Intervention Device: Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 75
Completed 67
Not Completed 8
Reason Not Completed
Withdrawal by Subject             4
Lost to Follow-up             2
Missed visit             2
Arm/Group Title Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
Hide Arm/Group Description

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 Number of Baseline Participants 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 75 participants
62.3  (8.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 75 participants
Female
26
  34.7%
Male
49
  65.3%
1.Primary Outcome
Title Major Adverse Event Rate
Hide Description [Not Specified]
Time Frame 9 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
Hide Arm/Group Description:

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 Number of Participants Analyzed 75
Measure Type: Number
Unit of Measure: percentage of participants
1.3
Time Frame All events that occured within 9 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
Hide Arm/Group Description

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.

All-Cause Mortality
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
Affected / at Risk (%) # Events
Total   29/75 (38.67%)    
Cardiac disorders   
Cardiac disorders  1  6/75 (8.00%)  9
Congenital, familial and genetic disorders   
Congenital, familial and genetic disorders  1  1/75 (1.33%)  1
Gastrointestinal disorders   
Gastrointestinal disorders  1  2/75 (2.67%)  2
General disorders   
General disorders and administration site conditions  1  1/75 (1.33%)  1
Infections and infestations   
Infections and infestations  1  3/75 (4.00%)  3
Injury, poisoning and procedural complications   
Injury, poisoning and procedural complications  1  7/75 (9.33%)  7
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Neoplasms benign, malignant and unspecified (incl cysts and polyps)  1  4/75 (5.33%)  4
Nervous system disorders   
Nervous system disorders  1  3/75 (4.00%)  3
Vascular disorders   
Vascular disorders  1  12/75 (16.00%)  18
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Protégé™ EverFlex™ and GPS™ Self-Expanding Stent Systems
Affected / at Risk (%) # Events
Total   44/75 (58.67%)    
Gastrointestinal disorders   
Gastrointestinal disorders  1  4/75 (5.33%)  4
General disorders   
General disorders and administration site conditions  1  14/75 (18.67%)  15
Injury, poisoning and procedural complications   
Injury, poisoning and procedural complications  1  11/75 (14.67%)  15
Metabolism and nutrition disorders   
Metabolism and nutrition disorders  1  4/75 (5.33%)  5
Musculoskeletal and connective tissue disorders   
Musculoskeletal and connective tissue disorders  1  13/75 (17.33%)  18
Respiratory, thoracic and mediastinal disorders   
espiratory, thoracic and mediastinal disorders  1  6/75 (8.00%)  6
Vascular disorders   
Vascular disorders  1  8/75 (10.67%)  8
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.

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

Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephanie Cihlar
Organization: Medtronic
Phone: 763-398-7932
EMail: stephanie.a.cihlar@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Endovascular
ClinicalTrials.gov Identifier: NCT01400919     History of Changes
Other Study ID Numbers: P-5684
First Submitted: July 21, 2011
First Posted: July 25, 2011
Results First Submitted: June 8, 2015
Results First Posted: June 24, 2015
Last Update Posted: March 7, 2018