Understanding Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging

Not Applicable

Withdrawn

• Conditions: Infrainguinal Peripheral Arterial Disease
• Interventions: Device: Standard PTA Balloon Angioplasty; Device: Chocolate PTA Balloon Angioplasty

• Registration Number: NCT02237066
• Lead Sponsor: TriReme Medical, LLC

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-09-03
• Study First Submitted QC: 2014-09-10
• Study First Posted: 2014-09-11
• Status Verified: 2015-03
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Last Update Submitted: 2015-03-17
• Last Update Posted: 2015-03-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard PTA Balloon	Standard PTA Balloon Angioplasty	Standard PTA Balloon Angioplasty
Chocolate PTA Balloon	Chocolate PTA Balloon Angioplasty	Chocolate PTA Balloon Angioplasty

Primary Outcome Measures

Name	Time	Method
Luminal Gain	Average of 90 minutes	Luminal Gain as defined by OCT lumen volume measurements. Luminal gain is assessed as the percentage change comparing pre-treatment and post-treatment volume measurements in cubic centimeters (CC) or millimeters (m3).

Secondary Outcome Measures

Name	Time	Method
Optimal PTA	Average of 90 minutes	Achievement of Optimal PTA (\<30% Diameter stenosis without flow limiting dissection); \<30% Diameter stenosis and flow limiting dissections are visual assessments that will be conducted by an independent core lab review. The % diameter stenosis measures the amount of plaque that is in the vessel and a flow-limiting dissection is observed as either present or not present.
Dissection	Average of 90 minutes	Dissection severity (extension) as defined by both angiographic and OCT metrics.; Dissections occur when the blood goes into the vessel wall instead of staying in the vessel lumen. Dissection severity is determined by a visual review of the angiogram and OCT images by an independent core lab. Dissections are classified as flow-limiting (more severe) vs. non-flow limiting (less severe) based upon the amount of the blood that is flowing into the vessel wall.
Hematoma	Average of 90 minutes	Presence of intramural hematoma on OCT.; A hematoma can be visually observed on a angiogram and an OCT image. The images will be independently reviewed by a core lab expert who will document if a hematoma is present or not.

Trial Locations

Locations (2)

Case Medical Center; 🇺🇸 Cleveland, Ohio, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States