Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)

• Sponsor: Integra LifeSciences Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03816202
• Collaborator: (none)
• Enrollment: 100
• Locations: 3
• Actual Duration (Months): 4.1
• Patients Per Site: 33.3
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief Summary

The primary objective of this study is to retrospectively investigate the safety and efficacy of the Integra Sundt™ carotid shunt during endarterectomy procedures.

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Stenosis	Device: Sundt carotid shunt

Study Design

• Study Type: Observational
• Actual Enrollment: 100 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Official Title: Sundt™ Carotid Shunt Retrospective Post Market Clinical Follow-up Study (PMCF)
• Actual Study Start Date: Apr 25, 2019
• Actual Primary Completion Date: Aug 27, 2019
• Actual Study Completion Date: Aug 27, 2019

Arms and Interventions

Arm	Intervention/Treatment
Sundt Carotid Shunt Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.	Device: Sundt carotid shunt; The Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion.

Outcome Measures

Primary Outcome Measures

1. Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal [up to 60 days post-procedure]

   Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Between the ages of 18-80 years old

• Have undergone carotid endarterectomy with any Integra Sundt™ carotid shunt on or before date of study initiation

• Availability of records on post-operative imaging of the carotid artery either by carotid duplex ultrasound or angiogram

Exclusion Criteria:

• Insertion of a carotid shunt at the site of an infection

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Research Institute of Deaconess Clinic	Newburgh	Indiana	United States	47630
2	Hackensack Meridian Health	Hackensack	New Jersey	United States	07601
3	The Mount Sinai Medical Center	New York	New York	United States	10029

Sponsors and Collaborators

• Integra LifeSciences Corporation

Investigators

• Study Director: Andrew Tummon, Integra LifeSciences

Study Documents (Full-Text)

• Study Protocol - Nov 28, 2018
• Statistical Analysis Plan - Dec 9, 2019

More Information

Publications

None provided.

• Responsible Party: Integra LifeSciences Corporation
• ClinicalTrials.gov Identifier: NCT03816202
• Other Study ID Numbers: C-SCS-001
• First Posted: Jan 25, 2019
• Last Update Posted: Jan 14, 2022
• Last Verified: Jan 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Carotid Stenosis

Study Results

Participant Flow

Arm/Group Title	Sundt Carotid Shunt
Arm/Group Description	Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.
Period Title: Overall Study
STARTED	100
COMPLETED	100
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Sundt Carotid Shunt
Arm/Group Description	Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt.
Overall Participants	100
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.5 (6.8)
Sex: Female, Male (Count of Participants)
Female	37 37%
Male	63 63%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	Evidence of Injury to the Artery or Cerebral Ischemia Secondary to Shunt Placement and Removal
Description	Number of participants with injury to the artery or cerebral ischemia secondary to shunt placement and removal
Time Frame	up to 60 days post-procedure

Outcome Measure Data

Analysis Population Description

number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal

Arm/Group Title	Sundt Carotid Shunt
Arm/Group Description	Subject has undergone a endarterectomy procedure with the use of the Sundt Carotid Shunt
Measure Participants	100
Count of Participants [Participants]	3 3%

Adverse Events

Time Frame	Retrospective chart review of AEs that occurred between Surgery (Day 0) and 60 days post-operatively.
Arm/Group Title	Sundt Carotid Shunt
Arm/Group Description	number of cases where there is evidence of injury to the artery or cerebral ischemia injury secondary to shunt placement and removal
All Cause Mortality
	Sundt Carotid Shunt
	Affected / at Risk (%)	# Events
Total	0/100 (0%)
Serious Adverse Events
	Sundt Carotid Shunt
	Affected / at Risk (%)	# Events
Total	0/100 (0%)
Other (Not Including Serious) Adverse Events
	Sundt Carotid Shunt
	Affected / at Risk (%)	# Events
Total	3/100 (3%)
Cardiac disorders
Artery injury	1/100 (1%)
Nervous system disorders
Cerebral Ischemia Injury	2/100 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT 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.