NCT04375085

DESyne X2 Post Market Follow-up Study

Terminated NA Results posted Last updated 25 October 2023

What this trial tests

NA trial testing Percutaneous Coronary Intervention in Coronary Artery Disease in 49 participants. Terminated before completion.

Timeline

1 September 2020

Primary endpoint
28 December 2021

28 December 2021

Quick facts

Lead sponsor	Elixir Medical Corporation
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	49
Start date	1 September 2020
Primary completion	28 December 2021
Estimated completion	28 December 2021
Sites	3 locations across China

Drugs / interventions tested

• Percutaneous Coronary Intervention

Conditions studied

• Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Elixir Medical Corporation

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Acute Success Primary · 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)

Group	Value	95% CI
Acute Success	49

Physician Assessment Was Performed After Each Case Secondary · Post procedure

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).

Device Preparation

Group	Value	95% CI
Patient Receiving the DESyne X2 Coronary Stent	4.6	4 – 5

Stent System Movement through Guiding Catheter

Group	Value	95% CI
Patient Receiving the DESyne X2 Coronary Stent	4.6	3 – 5

System track and flexibility

Group	Value	95% CI
Patient Receiving the DESyne X2 Coronary Stent	4.3	3 – 5

Stent Positioning

Group	Value	95% CI
Patient Receiving the DESyne X2 Coronary Stent	4.4	3 – 5

Stent and system visibility under Fluoroscopy/cine

Group	Value	95% CI
Patient Receiving the DESyne X2 Coronary Stent	4.5	4 – 5

Delivery system deployment of stent

Group	Value	95% CI
Patient Receiving the DESyne X2 Coronary Stent	4.4	4 – 5

Stent expansion to desired diameter

Group	Value	95% CI
Patient Receiving the DESyne X2 Coronary Stent	4.3	3 – 5

Stent recoil

Group	Value	95% CI
Patient Receiving the DESyne X2 Coronary Stent	4.4	2 – 5

Adverse events — posted to ClinicalTrials.gov

Time frame: Peri-procedurally. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Patients Receiving the DESyne X2 Coronary Stent

Serious: 0/49 (0%)

Deaths: 0/49

Other adverse events (2 terms — click to expand)

Reaction	System	Patients Receiving the DES…
procedure complication	Cardiac disorders	—
guidewire perforation	Cardiac disorders	—

Data from ClinicalTrials.gov NCT04375085 adverse events section.

Sponsor's own description

A single-arm post-market clinical follow-up study to confirm that the DESyne X2 delivery system performs similarly to the DESyne delivery system.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Real-World Clinical Performance of a Novolimus-Eluting Stent Versus a Sirolimus-Eluting Stent.
   Chang CC, Chang CC, Sung WT, Lu YW, et al · · 2024 · cited 2× · PMID 38953595 · DOI 10.1002/clc.24317