DESyne X2 Post Market Follow-up Study (DESyne X2 PMCF)

A Non-Randomized, Post Marketing Clinical Follow-Up (PMCF) Study of the DESyne X2 Novolimus Eluting Coronary Stent System in the Treatment of Patients With de Novo Native Coronary Artery Lesions

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

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Percutaneous Coronary Intervention

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 Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Tseung Kwan O Hospital
  • Kowloon
    • Hong Kong, Kowloon, China
      • Kwong Wah Hospital
    • Hong Kong, Kowloon, China
      • Queen Elizabeth Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DESyne X2 Novolimus Eluting Coronary Stent System	Device: Percutaneous Coronary Intervention; Percutaneous Coronary Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Success	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)	during procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Physician Assessment Was Performed After Each Case	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).	Post procedure

Collaborators and Investigators

• Sponsor: Elixir Medical Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): December 28, 2021
• Study Completion (Actual): December 28, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 5, 2020

Study Record Updates

• Last Update Posted (Actual): October 25, 2023
• Last Update Submitted That Met QC Criteria: October 23, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: percutaneous coronary intervention; coronary stent
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: ELX-CL-1705

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes