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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.
Full description
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
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Inclusion criteria
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
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
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44 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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