DESyne X2 Post Market Follow-up Study

Not Applicable

Terminated

• Conditions: Coronary Artery Disease
• Interventions: Device: Percutaneous Coronary Intervention

• Registration Number: NCT04375085
• Lead Sponsor: Elixir Medical Corporation

Brief Summary

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

Detailed Description

A single-arm post-market follow up study (PMCF) comparing the DESyne X2 PMCF data to the historic DESyne acute performance data to confirm the performance of the DESyne X2 Novolimus Eluting Coronary Stent System with regards to the residual risks of lesion access and acute device implantation through visually-assessed angiographic endpoints and physician feedback.

Study Timeline

• Study First Submitted: 2020-04-29
• Study First Submitted QC: 2020-05-04
• Study First Posted: 2020-05-05
• Study Start: 2020-09-01
• Primary Completion: 2021-12-28
• Study Completion: 2021-12-28
• Results First Submitted: 2023-09-05
• Status Verified: 2023-10
• Results First Submitted QC: 2023-10-23
• Last Update Submitted: 2023-10-23
• Results First Posted: 2023-10-25
• Last Update Posted: 2023-10-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. The patient must be ≥ 18 years of age.

2. The patient must have stable angina pectoris as defined by the Canadian Cardiovascular Society Classification, documented silent ischemia, acute coronary syndrome, or a positive functional study requiring treatment

3. The patient is considered a candidate for coronary stent implantation and has a planned intervention of up to two lesions located in separate major epicardial territories. Each lesion/vessel must meet the following criteria:

   1. De novo lesion
   2. The target lesion reference site must be visually estimated to be ≥ 2.5 mm and ≤ 4.0 mm in diameter
   3. The target vessel must be a major coronary artery or major branch with a visually estimated stenosis of ≥ 50% and < 100%.
   4. The visually estimated target lesion length must be ≤ 34 mm
   5. ≥ TIMI 1 coronary flow

Exclusion Criteria

1. The patient has a known hypersensitivity or contraindication to aspirin, heparin, ticlopidine, clopidogrel, prasugrel or ticagrelor, heparin/bivalirudin, mTOR inhibitor class drugs, cobalt chromium alloy, methacrylate or polylactide polymer, or sensitivity to contrast which cannot be adequately premedicated
2. Women of childbearing potential who have not undergone surgical sterilization or are not post-menopausal (defined as amenorrheic for at least one year) as well as women who are pregnant or nursing
3. Previous placement of a stent within 10 mm distal to the target lesion
4. Previous placement of a stent proximal to the target lesion
5. Total occlusion or < TIMI 1 coronary flow in the target vessel
6. The proximal target vessel or target lesion is severely calcified by visual assessment
7. Aorto-ostial location, unprotected left main lesion location, or a lesion within 5 mm of the origin of the left anterior descending or left circumflex
8. Lesion involvement of a significant side branch (branch diameter > 2 mm) that would be covered by stenting
9. High probability that treatment other than PTCA or stenting will be required for treatment of the same lesion
10. The target lesion, or the target vessel proximal to the target lesion, contains thrombus
11. The patient has suffered a myocardial infarction within the past 72 hours and the CK or CK-MB has not returned to normal at the time of the index procedure
12. The patient is a recipient of a heart transplant
13. The patient has extensive peripheral vascular disease that precludes safe sheath insertion or extreme anti-coagulation
14. The patient is currently participating in another investigational device or drug study that has not completed the primary follow-up phase
15. Patients who are unable or unwilling to cooperate with study procedures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DESyne X2 Novolimus Eluting Coronary Stent System	Percutaneous Coronary Intervention	-

Primary Outcome Measures

Name	Time	Method
Acute Success	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)

Secondary Outcome Measures

Name	Time	Method
Physician Assessment Was Performed After Each Case	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).

Trial Locations

Locations (3)

Kwong Wah Hospital; 🇨🇳 Hong Kong, Kowloon, China

Queen Elizabeth Hospital; 🇨🇳 Hong Kong, Kowloon, China

Tseung Kwan O Hospital; 🇨🇳 Hong Kong, China