Trial Outcomes & Findings for EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study (NCT NCT02066740)

NCT ID: NCT02066740

Last Updated: 2019-03-01

Results Overview

Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: Intra operative
• Results posted on: 2019-03-01

Participant Flow

Participant milestones

Measure	EverFlex™ Stent With Entrust™ Delivery System Subjects were treated with the EverFlex™ stent with Entrust™ delivery system
Overall Study STARTED	34
Overall Study COMPLETED	32
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

EverFlex™ Self-expanding Peripheral Stent With Entrust™ Delivery System Clinical Study

Baseline characteristics by cohort

Measure	EverFlex™ Stent With Entrust™ Delivery System n=34 Participants EverFlex™ stent with Entrust™ delivery system
Age, Continuous	71.5 years STANDARD_DEVIATION 9.4 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Germany	27 participants n=5 Participants
Region of Enrollment Sweden	7 participants n=5 Participants

PRIMARY outcome

Timeframe: Intra operative

Absence of stent elongation is achieved when the implanted stent length does not exceed the allowed stent length

Outcome measures

Measure	EverFlex™ Stent With Entrust™ Delivery System n=45 Number of Stents Implanted EverFlex™ stent with Entrust™ delivery system
Absence of Stent Elongation	95.6 percentage absence of stent elongation

PRIMARY outcome

Timeframe: Procedure

Successful stent deployment to be assessed based on stent delivery, lesion coverage and accuracy of deployment.

Outcome measures

Measure	EverFlex™ Stent With Entrust™ Delivery System n=45 Stents Implanted EverFlex™ stent with Entrust™ delivery system
Successful Stent Deployment	100.0 percentage - successful stent deployment

Adverse Events

EverFlex™ Stent With Entrust™ Delivery System

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	EverFlex™ Stent With Entrust™ Delivery System n=34 participants at risk EverFlex™ stent with Entrust™ delivery system
Gastrointestinal disorders Gastronintestinal disorders	2.9% 1/34 • Number of events 1 Only procedure-related AEs, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, and Unanticipated Serious Adverse Device Effects were required to be reported.
General disorders General disorders	2.9% 1/34 • Number of events 1 Only procedure-related AEs, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, and Unanticipated Serious Adverse Device Effects were required to be reported.
Infections and infestations Infections and infestations	2.9% 1/34 • Number of events 2 Only procedure-related AEs, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, and Unanticipated Serious Adverse Device Effects were required to be reported.
Renal and urinary disorders Renal and urinary disorders	5.9% 2/34 • Number of events 2 Only procedure-related AEs, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, and Unanticipated Serious Adverse Device Effects were required to be reported.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	2.9% 1/34 • Number of events 1 Only procedure-related AEs, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, and Unanticipated Serious Adverse Device Effects were required to be reported.
Surgical and medical procedures Surgical and medical procedures	2.9% 1/34 • Number of events 1 Only procedure-related AEs, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, and Unanticipated Serious Adverse Device Effects were required to be reported.
Vascular disorders Vascular disorders	5.9% 2/34 • Number of events 2 Only procedure-related AEs, Adverse Device Effects, Serious Adverse Events, Serious Adverse Device Effects, and Unanticipated Serious Adverse Device Effects were required to be reported.

Other adverse events

Adverse event data not reported

Additional Information

Stephanie Cihlar

Medtronic

Phone: 763-398-7932

Email: stephanie.a.cihlar@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and Sponsor \[or its agents\] that restricts PI's rights to discuss or publish trial results without permission of the Sponsor. Trial is still ongoing.
• Publication restrictions are in place

Restriction type: OTHER