Trial Outcomes & Findings for DESyne X2 Post Market Follow-up Study (NCT NCT04375085)

Last Updated: 2023-10-25

Results Overview

attainment of final result with \< 50% residual stenosis of the target site, using a DESyne X2 stent and standard pre-dilation catheters and post-dilatation catheters (if applicable)

Recruitment status

TERMINATED

Study phase

Target enrollment

49 participants

Primary outcome timeframe

during procedure

Results posted on

2023-10-25

Participant Flow

49 Patients were enrolled at 3 investigational sites in Hong Kong between 1 Sep 2020 to 28 Dec 2021. The enrollment was halted at 49 of 100 patients due to slow enrollment.

Participant milestones

Participant milestones
Measure	DESyne X2 Novolimus Eluting Coronary Stent System Enrollment of up to 100 patients with up to three de novo native coronary artery lesions receiving the DESyne X2 Novolimus Eluting Coronary Stent System (CSS).
Overall Study STARTED	49
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DESyne X2 Novolimus Eluting Coronary Stent System n=49 Participants Enrollment of up to 100 patients with up to three de novo native coronary artery lesions measuring between 2.25 and 4.0 mm in diameter and less than or equal to 34 mm in length receiving the DESyne X2 Novolimus Eluting Coronary Stent System (CSS).
Age, Categorical <=18 years	0 Participants n=49 Participants
Age, Categorical Between 18 and 65 years	27 Participants n=49 Participants
Age, Categorical >=65 years	22 Participants n=49 Participants
Sex: Female, Male Female	10 Participants n=49 Participants
Sex: Female, Male Male	39 Participants n=49 Participants
Region of Enrollment Hong Kong	49 participants n=49 Participants

PRIMARY outcome

Timeframe: during procedure

attainment of final result with \< 50% residual stenosis of the target site, using a DESyne X2 stent and standard pre-dilation catheters and post-dilatation catheters (if applicable)

Outcome measures

Outcome measures
Measure	Acute Success n=49 Participants The DESyne X2 Novolimus Eluting Coronary Stent System (NECSS) was able to be delivered to the target lesion in 100% of cases.
Acute Success	49 Participants

SECONDARY outcome

Timeframe: Post procedure

Population: Device preparation

A short questionnaire about device performance was included in the CRF. Device performance characteristics were rated on a scale of 1 to 5 (1 being poor performance and 5 being excellent performance).

Outcome measures

Outcome measures
Measure	Acute Success n=49 Participants The DESyne X2 Novolimus Eluting Coronary Stent System (NECSS) was able to be delivered to the target lesion in 100% of cases.
Physician Assessment Was Performed After Each Case Device Preparation	4.6 score on a scale Interval 4.0 to 5.0
Physician Assessment Was Performed After Each Case Stent System Movement through Guiding Catheter	4.6 score on a scale Interval 3.0 to 5.0
Physician Assessment Was Performed After Each Case System track and flexibility	4.3 score on a scale Interval 3.0 to 5.0
Physician Assessment Was Performed After Each Case Stent Positioning	4.4 score on a scale Interval 3.0 to 5.0
Physician Assessment Was Performed After Each Case Stent and system visibility under Fluoroscopy/cine	4.5 score on a scale Interval 4.0 to 5.0
Physician Assessment Was Performed After Each Case Delivery system deployment of stent	4.4 score on a scale Interval 4.0 to 5.0
Physician Assessment Was Performed After Each Case Stent expansion to desired diameter	4.3 score on a scale Interval 3.0 to 5.0
Physician Assessment Was Performed After Each Case Stent recoil	4.4 score on a scale Interval 2.0 to 5.0
Physician Assessment Was Performed After Each Case Stent conformability to vessel curvature	4.3 score on a scale Interval 3.0 to 5.0
Physician Assessment Was Performed After Each Case Delivery system withdrawal through stent and guide catheter	4.5 score on a scale Interval 4.0 to 5.0
Physician Assessment Was Performed After Each Case Stent re-cross of post dilatation catheter (as appropriate)	4.3 score on a scale Interval 4.0 to 5.0

Adverse Events

Patients Receiving the DESyne X2 Coronary Stent

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Patients Receiving the DESyne X2 Coronary Stent n=49 participants at risk There were 3 reported procedure complications including 2 cases of edge dissection treated with an additional DESyne X2 stent, and 1 case of a guidewire perforation in a non-target vessel during a non-target lesion treatment.
Cardiac disorders guidewire perforation	2.0% 1/49 • Number of events 1 • Peri-procedurally
Cardiac disorders procedure complication	4.1% 2/49 • Number of events 2 • Peri-procedurally

Additional Information

Candace Elek, EVP Clinical Research

Elixir Medical Corp

Phone: 4086362000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place