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

Primary Purpose

Infrainguinal Peripheral Arterial Disease

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chocolate PTA Balloon Angioplasty
Standard PTA Balloon Angioplasty
Sponsored by
TriReme Medical, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infrainguinal Peripheral Arterial Disease focused on measuring OCT, PTA, Balloon

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Case Medical Center
  • Cleveland Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Chocolate PTA Balloon

Standard PTA Balloon

Arm Description

Chocolate PTA Balloon Angioplasty

Standard PTA Balloon Angioplasty

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
September 3, 2014
Last Updated
March 17, 2015
Sponsor
TriReme Medical, LLC
Collaborators
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02237066
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Withdrawn
Why Stopped
Enrollment goals were not able to be met
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2015 (Anticipated)
Study Completion Date
March 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriReme Medical, LLC
Collaborators
University Hospitals Cleveland Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infrainguinal Peripheral Arterial Disease
Keywords
OCT, PTA, Balloon

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chocolate PTA Balloon
Arm Type
Experimental
Arm Description
Chocolate PTA Balloon Angioplasty
Arm Title
Standard PTA Balloon
Arm Type
Active Comparator
Arm Description
Standard PTA Balloon Angioplasty
Intervention Type
Device
Intervention Name(s)
Chocolate PTA Balloon Angioplasty
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Standard PTA Balloon Angioplasty
Intervention Description
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
Primary Outcome Measure Information:
Title
Luminal Gain
Description
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).
Time Frame
Average of 90 minutes
Secondary Outcome Measure Information:
Title
Dissection
Description
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.
Time Frame
Average of 90 minutes
Title
Hematoma
Description
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.
Time Frame
Average of 90 minutes
Title
Optimal PTA
Description
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.
Time Frame
Average of 90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sahil A Parikh, MD
Organizational Affiliation
Harrington Heart and Vascular Institute University Hospitals Case Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Case Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

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

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