This first in human feasibility study is designed to evaluate the feasibility MD-SBA DES in subjects undergoing percutaneous coronary intervention (PCI) to treat bifurcation lesions.
This is a prospective, single-arm, single-center initial feasibility clinical study enrolling subjects with symptomatic ischemic heart disease due to a de novo coronary bifurcation lesion. The objective is to obtain initial insights into the clinical safety of the device-specific aspects of the procedure; whether the device can be successfully delivered and implanted; whether there are any operator technique challenges with device use; human factors; clinical safety of the device and whether the device performs in accordance with its intended purpose. All enrolled subjects will be treated with the study device during the index procedure and followed after treatment to assess procedural success, clinical safety, and device performance. Follow-up is conducted through 3 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
13
The MD-SBA DES System is a single use, minimally invasive combination product that consists of a cobalt chromium metal coronary stent, coated with sirolimus in a PEA/BHT matrix, on a rapid exchange (RX) delivery system.
Cirugía Cardiovascular, Sanatorio Italiano
Asunción, Paraguay
Procedure Success
To determine whether the device can be successfully delivered and implanted, as measured by attainment of \<30% final residual stenosis of the target lesion and no in-hospital major adverse cardiac events (MACE).
Time frame: Periprocedural
MACE
Percentage of subjects with major adverse cardiac events, defined as cardiac death, myocardial infarction, emergency coronary artery bypass surgery, or clinically driven target lesion revascularization. Components of MACE, including cardiac death and myocardial infarction, may also be summarized.
Time frame: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
TVF
Percentage of subjects with target vessel failure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target vessel revascularization.
Time frame: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
Target Lesion Revascularization of the Side Branch
Percentage of subjects requiring repeat treatment of the side branch by percutaneous or surgical methods.
Time frame: 30-days, 6-months, 1-year, 2-years, and 3-years post index procedure
Stent thrombosis
Percentage of subjects with late stent thrombosis.
Time frame: 6-months, 1-year, 2-years, and 3-years post index procedure
Acute Success
Percentage of subjects with successful device delivery and target lesion treatment, including final residual stenosis \<30% and adequate side branch flow.
Time frame: Index procedure
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Side Branch Access
Percentage of subjects with TIMI-3 flow in the side branch and/or need to re-cross the side branch after study device use.
Time frame: Index procedure
Bleeding / Vascular Complications
Percentage of subjects with bleeding or vascular complications.
Time frame: Hospital discharge
Procedure Time
Duration of the index procedure in minutes
Time frame: Index procedure
Fluoroscopy Time
Total fluoroscopy duration during index procedure in minutes
Time frame: Index procedure
Contrast Volume
Total volume of contrast media used during index procedure in milliliters
Time frame: Index procedure