Clinical trial NCT04375085: DESyne X2 Post Market Follow-up Study
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: coronary stent
percutaneous coronary intervention
Lead sponsor: Elixir Medical Corporation
Sponsor class: INDUSTRY
First posted: 2020-05-05
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, non-randomized
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acute Success
timeFrame: during procedure
Secondary outcomes:
measure: Physician Assessment Was Performed After Each Case
timeFrame: Post procedure
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Kwong Wah Hospital
state: Kowloon
city: Hong Kong
country: China
facility: Queen Elizabeth Hospital
state: Kowloon
city: Hong Kong
country: China
facility: Tseung Kwan O Hospital
Study officials:
References: