None listed
Conditions
Brief summary
This study aims to conduct a first in human, single arm, multicenter trial of the BD(TM) Sirolimus Drug Coated Balloon Catheter for the treatment of femoropopliteal arterial disease to assess the need for future clinical research to evaluate performance and safety.
Interventions
The BD (TM) Sirolimus Drug Coated Balloon Catheter consists of an over-the-wire (OTW) percutaneous transluminal angioplasty balloon catheter coated with sirolimus on the surface of the balloon. The procedure will use angiogram imaging while a interventional radiologist or vascular surgeon delivers the investigational device. This procedure is expected to take approximately 60 minutes. This is a one time intervention during participation of this clinical trial. In order to evaluate the success of
The BD (TM) Sirolimus Drug Coated Balloon Catheter consists of an over-the-wire (OTW) percutaneous transluminal angioplasty balloon catheter coated with sirolimus on the surface of the balloon. The procedure will use angiogram imaging while a interventional radiologist or vascular surgeon delivers the investigational device. This procedure is expected to take approximately 60 minutes. This is a one time intervention during participation of this clinical trial. In order to evaluate the success of this intervention, angiogram imaging will be done at six month follow up visit. this adherence is considered outside of normal standard of care operations.
Sponsors
Becton, Dickinson and Company (BD)
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 90 Years
Healthy volunteers
No
Inclusion criteria
Greater than or equal to 18 years of age Rutherford Clinical Category 2-4 Lesion greater than or equal to 70% stenosis by visual estimate Lesion Length greater than or equal to 3 cm and less than or equal to 17 cm Target reference vessel diameter of 5-6 mm and able to be treated with available device size matrix
Exclusion criteria
Less than or equal to 90 years of age Life expectancy of less than 2 years Participant has acute limb ischemia Severe Calcification as defined as PARC scoring system Participant is currently participating in an investigational drug or device study, or previously enrolled in a trial within the last 30 days prior to screening.
Outcome results
None listed