CREATE PAS: Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study

• Sponsor: Medtronic Endovascular (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00530504
• Collaborator: (none)
• Enrollment: 1,500
• Locations: 2
• Arm: 1
• Duration (Months): 80.1
• Patients Per Site: 750
• Patients Per Site Per Month: 9.4

Study Details

Study Description

Brief Summary

The purposes of this study are:

1. To provide additional safety and effectiveness information on the commercial use of Protégé™ GPS™ and Protégé™ RX Carotid Stent Systems and the SpiderFX™ Embolic Protection Device.

2. To evaluate rare and unanticipated adverse events.

3. To evaluate the physician level of experience with carotid artery stenting procedures with adverse event rates.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Disease	Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Carotid Revascularization With ev3 Arterial Technology Evolution Post Approval Study
• Study Start Date: May 1, 2007
• Actual Primary Completion Date: Jan 1, 2014
• Actual Study Completion Date: Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Device Device	Device: PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device; Carotid artery stenting with distal embolic protection.

Outcome Measures

Primary Outcome Measures

1. Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure. [30 Days]

   Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years and above

• Informed consent

• Intent to use the PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX and SpiderFX™ to treat carotid artery disease per Instructions for Use

• Meet Instruction for Use (IFU)/ Centers for Medicare & Medicaid Services (CMS)defined anatomical or clinical high risk criteria

Exclusion Criteria:

• Subjects with contraindications as outlined in the Instructions for Use

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stony Brook University Hospital	Stony Brook	New York	United States
2	Wellmont Medical Center	Kingsport	Tennessee	United States

Sponsors and Collaborators

• Medtronic Endovascular

Investigators

• Principal Investigator: Gary Ansel, MD, MidWest Cardiology Research Foundation
• Principal Investigator: Robert Safian, MD, William Beaumont Hospitals

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Click here for information on carotid artery disease.
• Click here for information on ev3 Endovascular Inc.

Publications

None provided.

• Responsible Party: Medtronic Endovascular
• ClinicalTrials.gov Identifier: NCT00530504
• Other Study ID Numbers: P-2611
• First Posted: Sep 17, 2007
• Last Update Posted: Mar 5, 2019
• Last Verified: Feb 1, 2019

• Keywords provided by Medtronic Endovascular: Carotid Artery Disease; Embolic Protection
• Additional relevant MeSH terms: Carotid Artery Diseases

Study Results

Participant Flow

Arm/Group Title	Stent and Protection Device
Arm/Group Description	PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
Period Title: Overall Study
STARTED	1500
COMPLETED	1348
NOT COMPLETED	152

Baseline Characteristics

Arm/Group Title	Intervention
Arm/Group Description	PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
Overall Participants	1500
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	72.5 (9.5)
Sex: Female, Male (Count of Participants)
Female	577 38.5%
Male	923 61.5%

Outcome Measures

1. Primary Outcome

Title	Composite Rate of Death, Ipsilateral CVA, Procedure-related CVA, or Myocardial Infarction (MI) at 30 Days Post-procedure.
Description	Combined incidence of Major Adverse Cardiac and Cerebrovascular Events (MACCE) defined as myocardial infarction (MI), ipsilateral cerebrovascular accident (CVA), procedure-related contralateral CVA, or death, within 30 days of implantation.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intervention
Arm/Group Description	PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
Measure Participants	1500
Number [participants]	99 6.6%

Adverse Events

Time Frame	30 Days
Arm/Group Title	Intervention
Arm/Group Description	PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
All Cause Mortality
	Intervention
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	553/1500 (36.9%)
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders	33/1500 (2.2%)	34
Cardiac disorders
Cardiac disorder	98/1500 (6.5%)	117
Ear and labyrinth disorders
Ear And Labyrinth Disorders	2/1500 (0.1%)	2
Eye disorders
Eye disorder	8/1500 (0.5%)	8
Gastrointestinal disorders
Gastrointestinal disorders	35/1500 (2.3%)	42
General disorders
General Disorders And Administrative Site Conditions	71/1500 (4.7%)	76
Hepatobiliary disorders
Hepatobiliary disorders	4/1500 (0.3%)	5
Immune system disorders
Immune System Disorders	2/1500 (0.1%)	2
Infections and infestations
Infections And Infestations	46/1500 (3.1%)	51
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications	19/1500 (1.3%)	20
Investigations
Investigations	15/1500 (1%)	16
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders	10/1500 (0.7%)	10
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorders	12/1500 (0.8%)	12
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)	4/1500 (0.3%)	4
Nervous system disorders
Nervous System Disorders	142/1500 (9.5%)	150
Psychiatric disorders
Psychiatric Disorders	11/1500 (0.7%)	11
Renal and urinary disorders
Renal And Urinary Disorders	26/1500 (1.7%)	28
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders	30/1500 (2%)	33
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders	3/1500 (0.2%)	3
Surgical and medical procedures
Surgical And Medical Procedures	29/1500 (1.9%)	29
Vascular disorders
Vascular Disorders	268/1500 (17.9%)	284
Other (Not Including Serious) Adverse Events
	Intervention
	Affected / at Risk (%)	# Events
Total	258/1500 (17.2%)
Blood and lymphatic system disorders
Blood And Lymphatic System Disorders	13/1500 (0.9%)	13
Cardiac disorders
Cardiac disorders	24/1500 (1.6%)	24
Ear and labyrinth disorders
Ear And Labyrinth Disorders	3/1500 (0.2%)	3
Eye disorders
Eye Disorders	17/1500 (1.1%)	17
Gastrointestinal disorders
Gastrointestinal Disorders	25/1500 (1.7%)	27
General disorders
General Disorders And Administrative Site Conditions	40/1500 (2.7%)	41
Hepatobiliary disorders
Hepatobiliary Disorders	1/1500 (0.1%)	1
Immune system disorders
Immune System Disorders	2/1500 (0.1%)	2
Infections and infestations
Infections And Infestations	39/1500 (2.6%)	47
Injury, poisoning and procedural complications
Injury, Poisoning And Procedural Complications	12/1500 (0.8%)	12
Investigations
Investigations	16/1500 (1.1%)	17
Metabolism and nutrition disorders
Metabolism And Nutrition Disorders	7/1500 (0.5%)	8
Musculoskeletal and connective tissue disorders
Musculoskeletal And Connective Tissue Disorders	29/1500 (1.9%)	35
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms Benign, Malignant And Unspecified (Incl Cysts And Polyps)	3/1500 (0.2%)	3
Nervous system disorders
Nervous System Disorders	44/1500 (2.9%)	46
Psychiatric disorders
Psychiatric Disorders	7/1500 (0.5%)	7
Renal and urinary disorders
Renal And Urinary Disorders	19/1500 (1.3%)	20
Reproductive system and breast disorders
Reproductive System And Breast Disoders	1/1500 (0.1%)	1
Respiratory, thoracic and mediastinal disorders
Respiratory, Thoracic And Mediastinal Disorders	24/1500 (1.6%)	27
Skin and subcutaneous tissue disorders
Skin And Subcutaneous Tissue Disorders	10/1500 (0.7%)	11
Surgical and medical procedures
Surgical And Medical Procedures	10/1500 (0.7%)	14
Vascular disorders
Vascular Disorders	29/1500 (1.9%)	29

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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.