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

Understanding the Mechanism of Peripheral Arterial Balloon Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging

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.

Study Overview

• Status: Withdrawn
• Conditions: Infrainguinal Peripheral Arterial Disease
• Intervention / Treatment: Device: Chocolate PTA Balloon Angioplasty; Device: Standard PTA Balloon Angioplasty

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 Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Cleveland, Ohio, United States, 44106
      • Case Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chocolate PTA Balloon; Chocolate PTA Balloon Angioplasty	Device: Chocolate PTA Balloon Angioplasty; OCT imaging of diseased vessel is treated with an Angioplasty Procedure using the Chocolate PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later
Active Comparator: Standard PTA Balloon; Standard PTA Balloon Angioplasty	Device: Standard PTA Balloon Angioplasty; OCT imaging of diseased vessel is treated with an Angioplasty Procedure using a standard PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Luminal Gain	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).	Average of 90 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dissection	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.	Average of 90 minutes
Hematoma	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.	Average of 90 minutes
Optimal PTA	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.	Average of 90 minutes

Collaborators and Investigators

• Sponsor: TriReme Medical, LLC
• Collaborators: University Hospitals Cleveland Medical Center
• Investigators: Principal Investigator: Sahil A Parikh, MD, Harrington Heart and Vascular Institute University Hospitals Case Medical Center

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): March 1, 2015
• Study Completion (Anticipated): March 1, 2015

Study Registration Dates

• First Submitted: September 3, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Estimate): March 19, 2015
• Last Update Submitted That Met QC Criteria: March 17, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: OCT; PTA; Balloon
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: Chocolate OCT