Peripheral Arterial Disease, Critical Limb Ischemia
Conditions
Brief summary
The study objective is to assess the ability to define and measure post treatment recoil in infrapopliteal arteries. Preliminary evidence as to the differences between serration angioplasty and standard balloon angioplasty as defined by post treatment recoil, lumen gain, and dissection will be collected.
Detailed description
Multi-center, feasibility study treating up to 20 atherosclerotic lesions in the infrapopliteal arteries. The study will capture angiographic imaging (pre, during, post, and post 15 mins) for all lesions, and a subset (up to 10) of IVUS imaging data (pre, post, and post 15 mins), to compare serration angioplasty vs standard angioplasty and its effects on vessel recoil and final diameter stenosis.
Interventions
DEVICESerranator
Serranator® PTA Serration Balloon Catheter manufactured by Cagent Vascular
DEVICEPOBA
Plain balloon angioplasty device
Sponsors
Cagent Vascular LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or female of \>18 years old. 2. Women of childbearing potential must have a negative urine pregnancy test within 7 days of index procedure. 3. Subject or subject's legal representative has been informed of the nature of the study, agrees to participate, and comply, and has signed the consent form. 4. Subject has Rutherford Clinical Category 3, 4, 5, or 6. Angiographic Inclusion Criteria: 1. Target lesion(s) has stenosis \>70% by visual assessment; 2. De-novo, or non-stented re-stenotic lesions; 3. Reference vessel diameter is between 2.5 mm and 3.5 mm, inclusive; 4. Target lesions involve infrapopliteal tibial arteries including pedal; 5. A target lesion may consist of one long or multiple serial lesions that are up to and including 12 cm in length; 6. If a second lesion is identified in another vessel, the second lesion can also be treated and if treated will be treated with the alternate treatment.
Exclusion criteria
1. Evidence of aneurysm or acute thrombus in the target vessel. 2. Subject has an allergy to contrast medium that cannot be pretreated. 3. Subject is pregnant or breastfeeding. Angiographic
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of post treatment recoil | 15 minutes post procedure | Obtain preliminary data on post treatment recoil in infrapopliteal arteries utilizing angiographic and IVUS data following serration angioplasty and standard angioplasty. |
Countries
Germany, United States
Contacts
Primary ContactRobert Giasolli
Outcome results
None listed