Trial Outcomes & Findings for DEFLECT I: Keystone Heart Embolic Deflection Trial (NCT NCT01448421)

Results Overview

Device ability to access and deploy in the aortic arch and position the device to cover all three vessels.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

37 participants

Primary outcome timeframe

During the procedure

Results posted on

2020-09-14

Participant milestones
Measure	Keystone Heart Embolic Deflection Device Protected Transcatheter Aortic Valve Replacement Keystone Heart Embolic Deflection Device: The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures.
Overall Study STARTED	37
Overall Study COMPLETED	37
Overall Study NOT COMPLETED	0

Withdrawal data not reported

DEFLECT I: Keystone Heart Embolic Deflection Trial

Baseline characteristics by cohort
Measure	Keystone Heart Embolic Deflection Device n=37 Participants Protected Transcatheter Aortic Valve Replacement Keystone Heart Embolic Deflection Device: The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment Netherlands	37 participants n=5 Participants

Timeframe: During the procedure

Device ability to access and deploy in the aortic arch and position the device to cover all three vessels.

Outcome measures
Measure	Keystone Heart Embolic Deflection Device n=37 Participants Protected Transcatheter Aortic Valve Replacement Keystone Heart Embolic Deflection Device: The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures.
Number of Patients Where the Device Accessed, Deployed and Was Positioned in the Aortic Arch (Device Performance)	33 Participants

Timeframe: 30 days follow-up

Incidence of investigational device- and investigational procedure-related serious adverse events

Outcome measures
Measure	Keystone Heart Embolic Deflection Device n=37 Participants Protected Transcatheter Aortic Valve Replacement Keystone Heart Embolic Deflection Device: The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures.
Number of Serious Adverse Events Related to Investigational Device and Procedure	0 serious adverse events

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

keystoneheart

Phone: 97246158005

Principal investigator is a sponsor employee Upon completion of the Clinical Trial the Principal Investigator and Sponsor shall co-operate in producing a report of the Clinical Trial. The Sponsor will provide the Institution and/or Principal Investigator with the necessary results, and the Institution and/or Principal Investigator will be authorized to publish the results.
Publication restrictions are in place

Restriction type: OTHER