Vascular disease Circulatory System
Conditions
Interventions
Percutaneous bypass of Chronic Total Occlusions in arteries of the leg. This involves placing a guidewire around a chronic total occlusion via the sub-intimal space and back into the artery under the
Sponsors
Imperial College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient has a chronic total occlusion of the femoral, popliteal, external iliac or common iliac requiring treatment 2. Male or female patient, aged =18 and =90 years at time of enrolment 3. Suitable for endovascular intervention (PTA or peripheral stenting) 4. Able and willing to give written informed consent
Exclusion criteria
Exclusion criteria: 1. Any of the following blood disorders, confirmed by the pre-assessment laboratory tests taken as standard of care, within the month before the procedure: 1.1. Anaemia with haemoglobin < 80g/L 1.2. Thrombopaenia with platelets = 50 000/mL 1.3. Coagulation disorder with INR = 1.5 2. If female, patient is pregnant or lactating at the time of enrolment or planning to become pregnant during the study time period 3. Patient has participated in another clinical study involving an investigational drug or investigational device within 30 days prior to enrolment or is scheduled to participate in another clinical study involving an investigational drug or investigational device during the course of this study. Patients enrolled in observational registries not involving investigational drug or investigational device may still be eligible 4. Patient is in custody or an institution 5. Patient has close affiliation with the study site or sponsor (e.g. employee, close relative of an employee)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured immediately after the procedure: 1. Incidence of peri-procedural Major Adverse Events 2. Success rate of target lesion crossing defined by crossing with a 0.014 inches guide wire from true lumen to true lumen | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured immediately after the procedure with the exception of late adverse events: 1. Number of deployment attempts until the guidewire enters true lumen 2. Distance between the distal cap and the re-entry point (using X-ray image post procedure and target catheter tip length as reference) 3. Time from first steps taken to insert the ePATH target catheter into vessel until successful lesion crossing, documented using fluoroscopic images/video timestamps 4, Incidence of late adverse events reported at 6-week follow-up | — |
Countries
England, United Kingdom
Contacts
Public ContactRobert Dickinson
Outcome results
None listed