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.
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
de novo native coronary artery lesions
North Shore Hospital
Auckland, New Zealand
Auckland City Hospital
Auckland, New Zealand
Middlemore Hospital
Auckland, New Zealand
Christchurch Hospital
Christchurch, New Zealand
Target Lesion (s) Failure
composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR
Time frame: 6 months
Target Lesion (s) Failure
composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR
Time frame: 1 month
Target Lesion (s) Failure
composite endpoint of cardiac death, target vessel MI and clinically-indicated TLR
Time frame: 12 month
cardiac death
death from a cardiac cause
Time frame: 1 month
Cardiac Death
death from a cardiac cause
Time frame: 6 months
Cardiac Death
death from a cardiac cause
Time frame: 12 months
Non-Cardiac Death
death from a non-cardiac cause
Time frame: 1 month
Non-Cardiac Death
death from a non-cardiac cause
Time frame: 6 months
Non-Cardiac Death
death from a non-cardiac cause
Time frame: 12 months
myocardial infarction
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Dunedin Hospital
Dunedin, New Zealand
Waikato Hospital
Hamilton, New Zealand
Wellington Hospital
Wellington, New Zealand
all
Time frame: 1 month
myocardial infarction
all
Time frame: 6 months
myocardial infarction
all
Time frame: 12 months
myocardial infarction
related to the target vessel
Time frame: 1 month
myocardial infarction
related to the target vessel
Time frame: 6 months
Target Lesion Revascularization
Clinically indicated repeat intervention within the target lesion
Time frame: 1 month
Target Lesion Revascularization
Clinically indicated repeat intervention within the target lesion
Time frame: 6 months
Target Lesion Revascularization
Clinically indicated repeat intervention within the target lesion
Time frame: 12 months
Target Vessel Revascularization
Clinically indicated repeat intervention within the target vessel
Time frame: 1 month
Target Vessel Revascularization
Clinically indicated repeat intervention within the target vessel
Time frame: 6 months
Target Vessel Revascularization
Clinically indicated repeat intervention within the target vessel
Time frame: 12 months
Device Thrombosis
definite and probable as classified by an Academic Research Consortium
Time frame: 1 month
Device Thrombosis
definite and probable as classified by an Academic Research Consortium
Time frame: 6 months
Device Thrombosis
definite and probable as classified by an Academic Research Consortium
Time frame: 12 months