Coronary Artery Disease
Conditions
Keywords
coronary stent, percutaneous coronary intervention
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.
Interventions
DEVICEPercutaneous Coronary Intervention
Percutaneous Coronary Intervention
Sponsors
Elixir Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective, non-randomized
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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: 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
China
Participant flow
Recruitment details
49 Patients were enrolled at 3 investigational sites in Hong Kong between 1 Sep 2020 to 28 Dec 2021. The enrollment was halted at 49 of 100 patients due to slow enrollment.
Participants by arm
| Arm | Count |
|---|---|
| DESyne X2 Novolimus Eluting Coronary Stent System Enrollment of up to 100 patients with up to three de novo native coronary artery lesions measuring between 2.25 and 4.0 mm in diameter and less than or equal to 34 mm in length receiving the DESyne X2 Novolimus Eluting Coronary Stent System (CSS). | 49 |
| Total | 49 |
Baseline characteristics
| Characteristic | DESyne X2 Novolimus Eluting Coronary Stent System | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 22 Participants | — |
| Age, Categorical Between 18 and 65 years | 27 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Hong Kong | 49 participants | — |
| Sex: Female, Male Female | 10 Participants | — |
| Sex: Female, Male Male | 39 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 49 |
| other Total, other adverse events | 3 / 49 |
| serious Total, serious adverse events | 0 / 49 |
Outcome results
Primary
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)
Time frame: during procedure
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Acute Success | Acute Success | 49 Participants |
Secondary
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).
Time frame: Post procedure
Population: Device preparation
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Acute Success | Physician Assessment Was Performed After Each Case | Device Preparation | 4.6 score on a scale |
| Acute Success | Physician Assessment Was Performed After Each Case | Stent System Movement through Guiding Catheter | 4.6 score on a scale |
| Acute Success | Physician Assessment Was Performed After Each Case | Stent and system visibility under Fluoroscopy/cine | 4.5 score on a scale |
| Acute Success | Physician Assessment Was Performed After Each Case | System track and flexibility | 4.3 score on a scale |
| Acute Success | Physician Assessment Was Performed After Each Case | Stent Positioning | 4.4 score on a scale |
| Acute Success | Physician Assessment Was Performed After Each Case | Delivery system deployment of stent | 4.4 score on a scale |
| Acute Success | Physician Assessment Was Performed After Each Case | Stent expansion to desired diameter | 4.3 score on a scale |
| Acute Success | Physician Assessment Was Performed After Each Case | Stent recoil | 4.4 score on a scale |
| Acute Success | Physician Assessment Was Performed After Each Case | Stent conformability to vessel curvature | 4.3 score on a scale |
| Acute Success | Physician Assessment Was Performed After Each Case | Delivery system withdrawal through stent and guide catheter | 4.5 score on a scale |
| Acute Success | Physician Assessment Was Performed After Each Case | Stent re-cross of post dilatation catheter (as appropriate) | 4.3 score on a scale |