Coronary Artery Disease
Conditions
Brief summary
The DynamX (Bioadaptor) study is a prospective, consecutive enrollment study designed to enroll up to 50 patients requiring treatment of a single, de novo lesion ≤ 24 mm in length located in a vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter. All patients be followed clinically at 30 days, 6 and 9 months, and 1, 2 and 3 years. All patients will undergo imaging (angiography and IVUS) follow-up with approximately one-half of the patients returning for follow up at 9 months and approximately one-half returning for follow up at 12 months.
Detailed description
The DynamX (Bioadaptor) study is a prospective, consecutive enrollment study designed to enroll up to 50 patients requiring treatment of a single, de novo lesion ≤ 24 mm in length located in a vessel ≥ 2.5 mm and ≤ 3.5 mm in diameter. All patients be followed clinically at 30 days, 6 and 9 months, and 1, 2 and 3 years. All patients will undergo imaging (angiography and IVUS) follow-up with approximately one-half of the patients returning for follow up at 9 months and approximately one-half returning for follow up at 12 months. At select centers, a subset of approximately 20 patients will undergo FFR pressure wire measurement at baseline and at follow-up (or at a minimum follow-up) in conjunction with the IVUS imaging, and will also undergo OCT imaging at 9 or 12 months. The primary safety endpoint is Target Lesion Failure at 6 months. TLF is a composite endpoint defined as cardiac death, target vessel MI, and clinically-indicated target lesion revascularization. The primary imaging/efficacy endpoints for those patients undergoing imaging follow-up is the change in mean in-device area and mean lumen area at 9 or 12 months compared to post-procedure as measured by IVUS. Co-primary imaging/efficacy endpoints for those patients undergoing imaging follow-up is late lumen loss as measured by QCA and IVUS at 9 or 12 months.
Interventions
DEVICEPercutaneous Coronary Intervention
Drug eluting stent implant
Sponsors
Elixir Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
All patients will undergo imaging (angiography and IVUS) follow-up with approximately one-half of the patients returning for follow up at 9 months and approximately one-half returning for follow up at 12 months.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
General Inclusion Criteria: 1. Patient must be at least 18 years of age. 2. Patient is able to verbally confirm understanding of risks, benefits and treatment alternatives of receiving the DynamX Novolimus Eluting Coronary Stent System (CSS) and he/she provides written informed consent, as approved by the appropriate Ethics Committee of the respective clinical site, prior to any clinical study related procedure. 3. Patient must have evidence of myocardial ischemia (e.g., stable or unstable angina, silent ischemia, positive functional study or electrocardiogram (ECG) changes consistent with ischemia) 4. Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery 5. Patient must agree to undergo all clinical study required follow-up visits, angiograms, and IVUS testing 6. Patient must agree not to participate in any other clinical study for a period of one year following the index procedure. Angiographic Inclusion Criteria - Target Lesion/Vessel 1. Target lesion must be located in a native coronary artery with a nominal vessel diameter of ≥ 2.5 and ≤3.5 mm assessed visually or by online QCA 2. Target lesion must measure ≤ 24 mm in length 3. Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and \< 90% with a TIMI flow of ≥ 2 4. The lesion must be successfully pre-dilated (less than 35% DS) prior to enrollment Angiographic Inclusion Criteria - non-Target Lesion/Vessel Treatment 1\. Treatment of a single, non-target lesion located in a separate major epicardial vessel (defined as LAD with septal and diagonal branches, LCX with obtuse marginal and/or ramus intermedius branches and RCA and any of its branches) attempted during the index procedure must be completed first using an approved 'olimus drug eluting stent. The segment must be located such that any injury that might occur during intervention can be clearly attributable to the treated non-target vessel. If the procedure is deemed uncomplicated and optimal, treatment of the target lesion with the DynamX stent can be considered. Optimal lesion/vessel treatment defined as: * \< 10% but no more than 15% residual diameter stenosis by visual assessment * no evidence of dissection * no evidence of thrombus in the treated lesion or vessel * TIMI 3 flow * Stent completely covers lesion and extends to healthy vessel on both sides (healthy to healthy) General
Exclusion criteria
1. Patient has a known diagnosis of acute myocardial infarction (AMI) within 72 hours preceding the index procedure and CK and CK-MB have not returned within normal limits at the time of procedure 2. Patient is currently experiencing clinical symptoms consistent with AMI 3. Patient requires the use of any rotablator intervention during the index procedure 4. Patient has current unstable arrhythmias 5. Patient presenting with heart failure, chronic arrhythmia, COPD or lung function impairment 6. Patient has a known left ventricular ejection fraction (LVEF) \< 30% 7. Patient has received a heart transplant or any other organ transplant or is on a waiting list for any organ transplant 8. Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure 9. Patient is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.) 10. Patient is receiving chronic anticoagulation therapy (e.g., heparin, coumadin) that cannot be stopped and restarted according to local hospital standard procedures. 11. Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, Novolimus, CoCr alloys, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated 12. Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors. 13. Patient has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3, a WBC of \< 3,000 cells/mm3, or documented or suspected liver disease. 14. Patient has known renal insufficiency (e.g., serum creatinine level of more than 2.5 mg/dL, or patient on dialysis) 15. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions 16. Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months 17. Patient has had a significant GI or urinary bleed within the past six months 18. Patient has extensive peripheral vascular disease that precludes safe 6 French sheath insertion 19. Patient has other medical illness (e.g., cancer or congestive heart failure) or known history of substance abuse (alcohol, cocaine, heroin etc.) that may cause non-compliance with the clinical study plan, confound the data interpretation or is associated with a limited life expectancy (i.e., less than one year) 20. Patient is already participating in another clinical study which has not reached the primary endpoint (long-term follow-up is not an exclusion) 21. 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 22. Patient is unable to give their consent, is legally incompetent, or is institutionalized by virtue of an order issued by the courts or other authority Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Late Lumen Loss (LLL) as measured by QCA | 9 or 12 months | — |
| Late Lumen Loss (LLL) as measured by IVUS | 9 or 12 months | — |
| Target Lesion Failure (TLF) | 6 months | Target Lesion Failure (composite of cardiac death, target vessel MI, and clinically-indicated target lesion revascularization) |
| Change in Mean In-Device Area compared to post-procedure as measured by IVUS | 9 or 12 months | — |
| Change in Mean Lumen Area compared to post-procedure as measured by IVUS | 9 or 12 months | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Death | 30 days, 180 days, 1, 2 and 3 years | Cardiac Death |
| Non-Cardiac Death | 30 days, 180 days, 1, 2 and 3 years | Non-Cardiac death |
| Q-wave Myocardial Infarction (Q-MI) | 30 days, 180 days, 1, 2 and 3 years | Q-MI |
| Non-Q-wave Myocardial Infarction (NQ-MI) | 30 days, 180 days, 1, 2 and 3 years | NQ-MI |
| Target Vessel Myocardial Infarction (TV-MI) | 30 days, 180 days, 1, 2 and 3 years | Target Vessel MI |
| Non-Target Vessel Myocardial Infarction (NTV-MI) | 30 days, 180 days, 1, 2 and 3 years | Non-Target Vessel MI |
| Clinically-Indicated Target Lesion Revascularization (CI-TLR) | 30 days, 180 days, 1, 2 and 3 years | CI-TLR |
| Non-Clinically Indicated Target Lesion Revascularization (Non-CI-TLR) | 30 days, 180 days, 1, 2 and 3 years | Non-CI-TLR |
| Clinically Indicated Target Vessel Revascularization (CI-TVR) | 30 days, 180 days, 1, 2 and 3 years | CI-TVR |
| Non-Clinically Indicated Target Vessel Revascularization | 30 days, 180 days, 1, 2 and 3 years | Non-CI-TVR |
| Target Vessel Failure (TVF) | 30 days, 180 days, 1, 2 and 3 years | Composite of cardiac death, target vessel MI, clinically indicated target vessel revascularization |
| Stent Thrombosis | 30 days, 180 days, 1, 2 and 3 years | Definite & Probable Stent Thrombosis (per ARC) |
| Device Success | During Procedure | Successful delivery of the device and a final residual stenosis \< 30% by QCA |
| Procedure Success | In Hospital through Discharge | Successful delivery of the device and a final residual stenosis \< 30% by QCA without TLF through hospital discharge |
| Target Lesion Failure (TLF) | 30 days, 1, 2 and 3 years | Target Lesion Failure (composite of cardiac death, target vessel MI, and clinically-indicated target lesion revascularization) |
Other
| Measure | Time frame | Description |
|---|---|---|
| % Diameter Stenosis (DS) | During Procedure | % DS by QCA |
| Change in mean and minimum lumen, stent and vessel areas from post-procedure | 9 or 12 months | Change in mean lumen are, device area and vessel area by IVUS |
| In-stent % neointimal obstruction | 9 or 12 months | In-stent % neointimal obstruction by IVUS |
| In-stent late lumen loss (LLL) | 9 or 12 months | In-stent late lumen loss (LLL) byIVUS |
| Vasomotion (Pulsatility) | 9 or 12 months | Vasomotion (Pulsatility) assessment at during systole and diastole by IVUS |
| Stent malapposition | During procedure, 9 or 12 months | Acute, persistent and late stent malapposition by IVUS |
| Fractional Flow Reserve (FFR) | During procedure, 9 or 12 months | FFR measurements in the treated vessel |
| Assessment of disengagement segments | 9 or 12 months | Assessment of disengagement segments by OCT |
| Incomplete scaffold/device apposition | 9 or 12 months | Incomplete scaffold/device apposition by OCT |
| Scaffold/Device Area and Lumen Area | 9 or 12 months | Scaffold/Device Area and Lumen Area on OCT |
| Acute Recoil | During Procedure | Acute Recoil by QCA |
| Minimum Lumen Diameter (MLD) | During Procedure | MLD by QCA |
| Late Lumen Loss (LLL) | 9 months | Late lumen loss (in-stent and in-segment) by QCA |
Countries
Belgium, Italy
Outcome results
None listed