Clinical trial NCT02237066: Understanding Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging
Official title: Understanding the Mechanism of Peripheral Arterial Balloon Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Infrainguinal Peripheral Arterial Disease
Keywords: OCT
PTA
Balloon
Lead sponsor: TriReme Medical, LLC
Sponsor class: INDUSTRY
Collaborators: name: University Hospitals Cleveland Medical Center
First posted: 2014-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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 the full discretion of the physician and according to the standard practice at the hospital and the device Instructions for Use. All patients will undergo baseline OCT imaging in addition to standard angiography. Post-PTA, all patients will then undergo repeat OCT imaging immediately post-procedure and then again at 10-minutes post-procedure to assess for vascular recoil.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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.

Primary outcomes:
measure: Luminal Gain
timeFrame: Average of 90 minutes
Secondary outcomes:
measure: Dissection
timeFrame: Average of 90 minutes
measure: Hematoma
timeFrame: Average of 90 minutes
measure: Optimal PTA
timeFrame: Average of 90 minutes
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Case Medical Center
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Harrington Heart and Vascular Institute University Hospitals Case Medical Center
name: Sahil A Parikh, MD
role: PRINCIPAL_INVESTIGATOR
References: