Status:
WITHDRAWN
Understanding Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging
Lead Sponsor:
TriReme Medical, LLC
Collaborating Sponsors:
University Hospitals Cleveland Medical Center
Conditions:
Infrainguinal Peripheral Arterial Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 Q...
Detailed Description
Subjects will be randomized to treatment with either the Chocolate Balloon catheter or a standard balloon angioplasty catheter. All angioplasty procedures will be conducted with treatment balloon at t...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02237066
Start Date
September 1 2014
End Date
March 1 2015
Last Update
March 19 2015
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Case Medical Center
Cleveland, Ohio, United States, 44106
2
Cleveland Clinic
Cleveland, Ohio, United States, 44195