DESyne X2 PMCF: DESyne X2 Post Market Follow-up Study

• Sponsor: Elixir Medical Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04375085
• Collaborator: (none)
• Enrollment: 49
• Locations: 3
• Arm: 1
• Actual Duration (Months): 16
• Patients Per Site: 16.3
• Patients Per Site Per Month: 1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Device: Percutaneous Coronary Intervention	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Prospective, non-randomizedProspective, non-randomized
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Sep 30, 2020
• Actual Primary Completion Date: Jan 31, 2022
• Actual Study Completion Date: Jan 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

4. De novo lesion

5. The target lesion reference site must be visually estimated to be ≥ 2.5 mm and ≤ 4.0 mm in diameter

6. The target vessel must be a major coronary artery or major branch with a visually estimated stenosis of ≥ 50% and < 100%.

7. The visually estimated target lesion length must be ≤ 34 mm

8. ≥ 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kwong Wah Hospital	Hong Kong	Kowloon	China
2	Queen Elizabeth Hospital	Hong Kong	Kowloon	China
3	Tseung Kwan O Hospital	Hong Kong		China

Sponsors and Collaborators

• Elixir Medical Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elixir Medical Corporation
• ClinicalTrials.gov Identifier: NCT04375085
• Other Study ID Numbers: ELX-CL-1705
• First Posted: May 5, 2020
• Last Update Posted: Feb 1, 2022
• Last Verified: Jan 1, 2022

• 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
• Keywords provided by Elixir Medical Corporation: coronary stent; percutaneous coronary intervention
• Additional relevant MeSH terms: Coronary Artery Disease

Study Results

No Results Posted as of Feb 1, 2022