CHORONARY MGUARD PRIME MGP4028 TRIAL
Currently enrolled in another investigational device or drug trial that has not reached the primary endpoint or that clinically interferes with the current study endpoints.The entire lesion length requiring treatment is ≤33 mm by visual assessment, assessed after TIMI 2/3 flow is restored.
Mm by visual assessment, assessed after TIMI 2/3 flow is restored. The reference vessel diameter (RVD) of the infarct lesion is 2.75-4.0.TIMI flow of 0/1 is present at baseline and TIMI flow of 2/3 is present prior to randomization.Based on coronary anatomy, PCI is indicated for the culprit lesion with anticipated use of stenting.The target lesion is a single de novo lesion in a native coronary artery.Subject provides written, informed consent.Subject agrees to all required follow-up procedures and visits.ST-segment elevation ≥1 mm per lead in ≥2 contiguous leads is present in at least one ECG prior to consent.Subject is experiencing clinical symptoms consistent with acute myocardial infarction (AMI) of >30 minutes and ≤12 hours in duration.I look forward to reviewing and analyzing all of the CARENET data over the next several weeks and sharing the results soon afterward. The CGuard technology provides an elegantly simple solution for embolic protection that has not been available in the past. The small pore size of the MicroNet technology allows excellent blood flow while trapping potentially harmful plaque debris and thrombus. I have treated many patients with carotid artery disease over the years, and the unique CGuard embolic protection system with MicroNet has changed the way I think about treating these challenging patients. The experience that we have gained using the CGuard device has given us a sense of confidence in regards to new technology options when treating these patients. The company intends to pursue regulatory applications for the MicroNet technology in the CGuard for carotid indications, as well as in its devices for coronary and peripheral artery procedures.ĬARENET investigator Professor Joachim Schofer, MD, from the Hamburg University Cardiovascular Center in Hamburg, Germany, commented on the device in the company’s press release: “I am excited that enrollment in the CGuard CARENET study has just been completed. The aperture of the MicroNet pore is 150 to 180 microns in order to maximize protection against the potentially dangerous plaque and thrombus within the carotid artery. The MicroNet technology is a single-fiber knitted mesh wrapped on an open-cell stent platform designed to trap debris that can dislodge and travel downstream after a patient is treated with traditional stenting methods. The company advised that the proprietary CGuard carotid EPS uses the same MicroNet technology featured on the MGuard and MGuard Prime coronary EPS.
Ultrasound examination is planned for 30 days and 1 year on every patient. In addition, diffusion-weighted magnetic resonance imaging is being done before and after the procedure and at 30 days. Patients will be followed using traditional assessments postprocedure and at 30 days to include major adverse cardiovascular events (MACE including death, stroke, myocardial infarction) and ipsilateral stroke (31 days to 1 year). The company plans to present the CARENET trial data at the TCT 2014: Transcatheter Cardiovascular Therapeutics conference to be held September 13 through 17 in Washington, DC.Īccording to InspireMD, the CARENET study enrolled 30 patients at four sites across Europe. InspireMD stated that acute procedural performance success of the CGuard device was 100% for all of the 30 patients enrolled in the trial. announced that it has completed enrollment in its CARENET clinical trial assessing the periprocedural safety and efficacy of the company’s CGuard embolic protection system (EPS) in the treatment of carotid lesions. The CARENET trial was conducted by a multispecialty team of investigators, including interventional cardiologists, interventional radiologists, and vascular surgeons.
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