PMS Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention

• Sponsor: Gardia Medical (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02373852
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Duration (Months): 20
• Patients Per Site Per Month: 0.6

Study Details

Study Description

Brief Summary

The objective of this study is to collect data on the use of the WIRION system in Patients undergoing Percutaneous Intervention of Saphenous Vein Graft (SVG).

Condition or Disease	Intervention/Treatment	Phase
Stenosis	Device: Saphenous vein graft (SVG) stenting

Detailed Description

WIRION system is used as protection device in patients undergoing SVG stenting procedure. This retrospective study collects data on the usability of the WIRION during the procedure.

Study Design

• Study Type: Observational
• Actual Enrollment: 12 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Post Marketing Surveillance (PMS) Retrospective Study of WIRION Performance in Patients Undergoing Saphenous Vein Graft (SVG) Intervention
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: May 1, 2015
• Actual Study Completion Date: Jun 1, 2016

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure [30 Days]

   Collect and analyse all adverse events occurred during and following the SVG procedure up to 30 days.

2. Number of Patients That Undergo Successful SVG Procedure [30 Days]

   Successful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred.

Eligibility Criteria

Criteria

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

Inclusion Criteria:

• Patients underwent percutaneous intervention (PI) of SVG stenting in which the WIRIONTM system was used.

• Patient is greater than or equal to 18 years of age.

Exclusion Criteria:

• Undergone cardiac surgery in the past 60 days before the procedure.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bnai Zion	Haifa		Israel

Sponsors and Collaborators

• Gardia Medical

Investigators

• Study Director: Vardit Segal, PhD, Gardia medical manufacture the WIRION used in the study

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gardia Medical
• ClinicalTrials.gov Identifier: NCT02373852
• Other Study ID Numbers: SVG-CL003
• First Posted: Feb 27, 2015
• Last Update Posted: Sep 12, 2019
• Last Verified: Aug 1, 2019

Study Results

Participant Flow

Arm/Group Title	WIRION
Arm/Group Description	Patients undergoing SVG stenting procedure with the use of the WIRION
Period Title: Overall Study
STARTED	12
COMPLETED	11
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	WIRION
Arm/Group Description	Patients undergoing SVG stenting procedure with the use of the WIRION
Overall Participants	12
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	71.7 (8.8)
Sex: Female, Male (Count of Participants)
Female	1 8.3%
Male	11 91.7%
Race and Ethnicity Not Collected (Count of Participants)
Region of Enrollment (participants) [Number]
Israel	12 100%
Diabetes (Count of Participants)
Count of Participants [Participants]	10 83.3%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Adverse Events During the Procedure and up to 30 Days Following Procedure
Description	Collect and analyse all adverse events occurred during and following the SVG procedure up to 30 days.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WIRION
Arm/Group Description	Patients undergoing SVG stenting procedure with the use of the WIRION
Measure Participants	12
Count of Participants [Participants]	5 41.7%

2. Primary Outcome

Title	Number of Patients That Undergo Successful SVG Procedure
Description	Successful procedure is considered as a procedure in which no distal embolization, dissection, perforation, abrupt closure or no reflow occurred.
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	WIRION
Arm/Group Description	Patients undergoing SVG stenting procedure with the use of the WIRION
Measure Participants	12
Count of Participants [Participants]	12 100%

Adverse Events

Arm/Group Title	WIRION
Arm/Group Description	Patients undergoing SVG stenting procedure with the use of the WIRION
All Cause Mortality
	WIRION
	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)
Serious Adverse Events
	WIRION
	Affected / at Risk (%)	# Events
Total	1/12 (8.3%)
Cardiac disorders
Death	1/12 (8.3%)
Other (Not Including Serious) Adverse Events
	WIRION
	Affected / at Risk (%)	# Events
Total	4/12 (33.3%)
Cardiac disorders
Chest pain on effort	4/12 (33.3%)	4

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.