DynamX Sirolimus Study Sirolimus Eluting Coronary Bioadaptor System

Study Overview
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Brief Summary
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To confirm the safety and performance of the DynamX Sirolimus-eluting Coronary Bioadaptor System (SECBS) in de novo native coronary artery lesions using clinical and imaging endpoints. Clinical follow-up will be conducted in all patients at 30 days, 6 and 12 months. Imaging follow-up will be conducted at 6 months.

Detailed Description
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The DynamX Sirolimus Study is a prospective, consecutive enrollment, single-arm study designed to enroll up to 30 patients requiring treatment of up to two de novo lesions ≤ 24 mm in length in vessels ≥ 2.5 mm and ≤ 3.5 mm in diameter. One or two designated target lesions, located in separate epicardial vessels (RCA, LCX or LAD), and meeting the inclusion/exclusion criteria may be treated with the DynamX SECBS. Alternatively, one target lesion may be treated with the DynamX SECBS after successful, uncomplicated treatment of a non-target lesion, located in a separate epicardial vessel, with any commercially-available DES. Acceptable example: non-target RCA lesion and LAD target lesion. Not acceptable example: LAD non-target lesion and 1st diagonal target lesion. 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 efficacy endpoint is late lumen loss at 6 months, assessed by angiography Additional secondary safety and effectiveness endpoints will be evaluated at 30 days, 6 and 12 months Using visual assessment, the target lesion must measure ≥ 2.5 mm and ≤ 3.5 mm in diameter and ≤ 24 mm in length able to be covered by a single DynamX Sirolimus Bioadaptor including 2 mm of healthy vessel on either side of the planned treatment area. The patient will be eligible for stent (also called bioadaptor) implantation only after satisfactory lesion pre-dilatation defined as: ≥ TIMI 2 flow, and no dissection greater than Grade B (NHLBI) able to be covered with a single DynamX SECBS

Official Title
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Evaluation of a Thin Strut Metallic Coronary Device: the Elixir DynamXTM Sirolimus Eluting Coronary Bioadaptor System

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Device: DynamX Sirolimus-eluting Coronary Bioadaptor System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient must be at least 18 years of age Patient is able to understand the risks, benefits and treatment alternatives of receiving the DynamX Sirolimus Eluting CBS and provide written informed consent, as approved by the NZ Ethics Committee, prior to any clinical study-related procedure 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) Patient must be an acceptable candidate for coronary artery bypass graft (CABG) surgery Women of childbearing potential with a negative pregnancy test within 7 days and women who are not pregnant or nursing Patient must agree to undergo all clinical study required follow up visits, angiograms, and imaging testing Patient must agree not to participate in any other clinical research study for a period of one year following the index procedure Angiographic inclusion criteria- Target Lesion/Vessel Target lesion(s) must be located in a native coronary artery with a vessel diameter of ≥ 2.5 and ≤3.5 mm assessed visually or by online QCA Target lesion(s) must measure ≤ 24 mm in length Target lesion(s) must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 90% with a TIMI flow of ≥ 2. When two target lesions are treated, they must be located in separate major epicardial vessels The lesion(s) must be successfully pre-dilated (less than 35% DS) prior to enrollment The target lesion length is 24 mm and able to be covered by a single DynamX Sirolimus Bioadaptor with 2 mm of healthy vessel on either side of planned implantation site Treatment of a single, non-target lesion located in a separate major epicardial vessel Exclusion Criteria: Patient has a diagnosis of ST elevation myocardial infarction (STEMI) within 72 hours preceding the index procedure, and CK and CK-MB have not returned within normal limits at the time of procedure Patient requires the use of rotational atherectomy during the index procedure Patient has current unstable ventricular arrhythmias Patient has a known left ventricular ejection fraction (LVEF) < 30% Patient has received a heart transplant or any other organ transplant or is on a waiting list for an organ transplant Patient is receiving or scheduled to receive chemotherapy for malignancy within 30 days prior to or after the procedure Patient is receiving immunosuppression therapy, other than steroids or has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus etc.) Patient has a known hypersensitivity or contraindication to aspirin, both heparin and bivalirudin, clopidogrel, prasugrel or ticagrelor, Sirolimus, CoCr alloys, PLLA polymers or contrast sensitivity that cannot be adequately pre-medicated Elective surgery is planned within the first 6 months after the procedure that will require discontinuing either aspirin or clopidogrel or other P2Y12 inhibitors. Patient has a platelet count < 100,000 cells/mm3 or > 700,000 cells/mm3, a WBC of < 3,000 cells/mm3, or documented liver disease. Patient has severe renal dysfunction (CKD IV or V, eGFR <30) or is on dialysis. Patient has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions Patient has had a cerebrovascular accident (CVA) or transient ischemic neurological attack (TIA) within the past six months Patient has had a significant GI or urinary bleed within the past six months Patient has a condition that precludes safe 6 French sheath insertion; or other medical conditions 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 associated with a limited life expectancy (i.e., less than one year) Patient is already participating in another clinical study which has not reached the primary endpoint (long-term follow-up is not an exclusion) Angiographic Exclusion Criteria Target Lesion/Vessel 1. Target/Vessel / Target lesion(s) meets any of the following criteria: Aorto-ostial location Left main location Located within 5 mm of the origin of the LAD or LCX Located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft Lesion involving a bifurcation with a side branch >2mm in diameter Previous placement of a stent within 10 mm of the target lesion Total or sub-total occlusion (TIMI flow ≤1) The proximal target vessel or target lesion is severely calcified by visual assessment, or the lesion prevents full pre-dilatation balloon expansion Previous intervention restenosis 2. The target vessel contains visible thrombus 3. Another clinically-significant lesion (>50%) is located in the same major epicardial vessel as the target lesion 5. Target vessel was previously treated with any type of PCI < 6 months prior to index procedure 6. Non-Target vessel was previously treated with any type of PCI < 30 days prior to the index procedure

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: prospective, consecutive enrollment, single-arm study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DynamX Sirolimus-eluting Coronary Bioadaptor System<br>2.5 - 3.5mm 14mm, 18mm and 28mm | Device: DynamX Sirolimus-eluting Coronary Bioadaptor System<br>* de novo native coronary artery lesions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion (s) Failure | composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target Lesion (s) Failure | composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR | 1 month | 
| Target Lesion (s) Failure | composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR | 12 month | 
| cardiac death | death from a cardiac cause | 1 month | 
| Cardiac Death | death from a cardiac cause | 6 months | 
| Cardiac Death | death from a cardiac cause | 12 months | 
| Non-Cardiac Death | death from a non-cardiac cause | 1 month | 
| Non-Cardiac Death | death from a non-cardiac cause | 6 months | 
| Non-Cardiac Death | death from a non-cardiac cause | 12 months | 
| myocardial infarction | all | 1 month | 
| myocardial infarction | all | 6 months | 
| myocardial infarction | all | 12 months | 
| myocardial infarction | related to the target vessel | 1 month | 
| myocardial infarction | related to the target vessel | 6 months | 
| Target Lesion Revascularization | Clinically indicated repeat intervention within the target lesion | 1 month | 
| Target Lesion Revascularization | Clinically indicated repeat intervention within the target lesion | 6 months | 
| Target Lesion Revascularization | Clinically indicated repeat intervention within the target lesion | 12 months | 
| Target Vessel Revascularization | Clinically indicated repeat intervention within the target vessel | 1 month | 
| Target Vessel Revascularization | Clinically indicated repeat intervention within the target vessel | 6 months | 
| Target Vessel Revascularization | Clinically indicated repeat intervention within the target vessel | 12 months | 
| Device Thrombosis | definite and probable as classified by an Academic Research Consortium | 1 month | 
| Device Thrombosis | definite and probable as classified by an Academic Research Consortium | 6 months | 
| Device Thrombosis | definite and probable as classified by an Academic Research Consortium | 12 months |