Understanding Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging
Withdrawn before enrolling · Not applicable
Conditions studied: Infrainguinal Peripheral Arterial Disease
In brief
The purpose of this study is to compare the Chocolate PTA Balloon to standard Percutaneous Transluminal Angioplasty (PTA) catheters. The investigators will use Optical Coherence Tomography (OCT) and Quantitative Vascular Angiography to evaluate the acute vascular response of vessels treated with the Chocolate Balloon to a standard balloon catheter, with the primary endpoint being luminal gain assessed by OCT lumen volume measurements.
Key facts
- Study ID
- NCT02237066
- Run by
- TriReme Medical, LLC
- People needed
- 0
- Starts
- 2014-09-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Reference Vessel Diameter (RVD) between 2.5 and 6.0mm and within treatment range of available balloon at Target Lesion
- Intermittent claudication or critical limb ischemia (Rutherford 3-5)
- De novo stenosis (≥70%) or occlusion in the infrainguinal arteries, including superficial femoral artery (SFA), popliteal, and infrapopliteal arteries.
- Lesion successfully crossed with a guide-wire
- Patient has given informed consent to participate in this study
You may not qualify if…
- Lesion requiring ablative procedures (i.e. atherectomy or laser) as part of treatment
- Lesion length >75mm
- Previous bypass or stent at target vessel or proximal to target vessel
- Significant in-flow disease at target lesion
- Known inadequate distal outflow disease or planned treatment of vessel distal to target lesion
- Acute limb ischemia or need for thrombolytic therapy
- Known intolerance to required study medications, contrast media, or nitinol
- Known impaired Renal Function with Glomerular Filtration Rate (GFR) <45 ml/min per 1.73m2
- Known bleeding disorder or uncontrolled hypercoagulable disorder.
Where it is running
- Case Medical Center — Cleveland, Ohio, United States
- Cleveland Clinic — Cleveland, Ohio, United States
Full record on ClinicalTrials.gov
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