None listed
Conditions
Brief summary
The objective of the proposed investigation is to assess the safety and performance of the Genesis Medtech Vascular Closure Device System used to close arterial access sites on patients undergoing endovascular interventions. The study will be a prospective non-randomized, single-arm trial of up to 12 patients enrolled in two centres. Appropriate patients will be enrolled in the study by the principal investigator (PI) at each site after obtaining informed consent. Patients will have a basic health screening history recorded pre-operatively; with a clinical exam at hospital discharge; and with visual inspection of the closure site from 14-30 days, post-procedure; the timing of this last review is left open to the discretion of the PI and to best coincide with the scheduled follow up for the original endovascular procedure. Other examinations will be performed as deemed necessary by the investigator. Safety will be evaluated by the incidence of adverse/serious adverse events at discharge (in clinic/hospital) and at the stated post-procedure follow-up intervals. Performance will be measured in terms of technical evaluation of the device deployment.
Interventions
The Genesis Medtech Innovation SureClose Vascular Closure Device (VCD) is indicated for use for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures.
The SureClose VCD is a small mechanical device with a built-in needle and suture which can assist your doctor in closing the access site with a neat and repeatable knot and closure. This study will be the first time that the Sur
The Genesis Medtech Innovation SureClose Vascular Closure Device (VCD) is indicated for use for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures. The SureClose VCD is a small mechanical device with a built-in needle and suture which can assist your doctor in closing the access site with a neat and repeatable knot and closure. This study will be the first time that the SureClose VCD will be tested in people. The study will help determine if the SureClose VCD can be used safely and successfully with positive outcomes for patient recovery and healing after their endovascular procedure. Participants will be selected for participation in this research because they will be undergoing scheduled endovascular procedure of the type which will need to have the arterial access site closed. The research doctor will explain the main procedure and will perform the pre-procedure assessments and scheduled procedure and follow-up as per standard of care. If participant agree to to take part in this study, the arterial puncture site will be closed using the experimental device at the end of the procedure. After the procedure participants will be will be closely followed-up for two to four weeks to check that your puncture site is healing as expected. The study schedule is as follows: • Screening First Consultation: Before any study-related procedures are done, the study doctor will explain the study and participants will have time to read the Participant Information and Consent Form and have the chance to ask any questions. Consent form will be signed if the participant decides to proceed. They will be given copy of the signed Participant Information and Consent Form to keep and the original copy will be put in your medical record. Your study doctor will also inform the participant’s local doctor (General Practitioner) that they participating in this research project. Participants should ask all other treating physicians to inform the study physician of any change in their medical condition, medications, including any emergency room visits and hospitalisations. Second Consultation: Participants have had time to consider their participation and after they have signed the consent form, the study doctor will ask you about and record your medical history and current medications to determine if they are eligible to participate in the study. If they are eligible, they will have a physical examination, vital signs recording that includes blood pressure, heart rate, temperature and weight. • Procedure Participants will have their scheduled endovascular procedure as per standard of care. The procedures will be conducted at The Alfred Hospital surgical theatre, 55 Commercial Road, Melbourne 3004. At the end of the endovascular procedure the catheter and any other devices used for your procedure will be removed from the artery as per standard process. The sterile, single-use SureClose would be inserted into the arterial puncture site and will be positioned appropriately. The research doctor may verify the location of the device by performing a quick ultrasound. This will cause no pain and can help ensure the safety of the procedure. Once the SureClose is verified to be in place, the study doctor will deploy the suture needle which will automatically stitch and connect the two sides of the access site wound together. The suture is then knotted by the SureClose and an accessory tool will be used by the study doctor to push the knot down the suture to the degree of tension which the study doctor judges to be appropriate. The excess suture is trimmed away and the access site is closed quickly, neatly and with minimal blood loss. The implantation of the CVD will take will take around 5-10 minutes. Following the procedure, the study doctor will test the area to ensure proper suture tension and verify that the closure is complete. Participants may notice bruising or tenderness in the area. This is normal and to be expected. There is no further action required unless any signs of unexpected bleeding or pain and tearing at the site. Signs of blood vessel damage should be reported to the study doctor immediately and will determine what additional steps are needed. Following your doctor’s recommended visit plan for your endovascular procedure, they will also inspect the access site to ensure proper healing but no further action will be required on your part. The sutures do not need to be removed, so there will be no additional procedures required at the access site. • Follow-Up at Discharge and at a hospital visit 2 to 4 weeks after the procedure The access site will be assessed to check that it is healing as expected. The follow-up consultation is at 2 - 4 weeks will take about half an hour. Any adverse events will be recorded for the duration of the study.
Sponsors
Genesis Medtech Innovation Private Limited
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Inclusion Criteria - Patients must meet all of the following: • Patient health is amenable to vascular closure; • Are at least 18 years old at time of entry into the study; • Signed informed consent form.
Exclusion criteria
Exclusion Criteria - Patients will be excluded should they meet any of the following: • Patients with compromised immune systems or health conditions which would delay or otherwise extend healing past the proposed discharge timing of the study, i.e., 14-30 days post-procedure; • Pregnant women; • Patients with the access puncture site is located in the superficial femoral artery or the profunda femoris artery, or the bifurcation of these vessels, since such puncture sites may result in a pseudoaneurysm, intimal dissection, or an acute vessel closure; • Patients who have experienced a recent (within 1 week) acute myocardial infarction or stroke; • Pre-existing AV fistula; • Pre-existing Pseudoaneurysm; • Access site-related nerve injury; • Clinical condition preventing patient from participating in the study; • Contraindications to index procedure medications (heparin, aspirin, clopidogrel, and radiographic contrast).
Outcome results
None listed