NCT02237066

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2014

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 11, 2014

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

March 19, 2015

Status Verified

March 1, 2015

Enrollment Period

6 months

First QC Date

September 3, 2014

Last Update Submit

March 17, 2015

Conditions

Infrainguinal Peripheral Arterial Disease

Keywords

OCTPTABalloon

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Dissection

    Average of 90 minutes

  • Hematoma

    Average of 90 minutes

  • Optimal PTA

    Average of 90 minutes

Study Arms (2)

Chocolate PTA Balloon

EXPERIMENTAL

Chocolate PTA Balloon Angioplasty

Device: Chocolate PTA Balloon Angioplasty

Standard PTA Balloon

ACTIVE COMPARATOR

Standard PTA Balloon Angioplasty

Device: Standard PTA Balloon Angioplasty

Interventions

Chocolate PTA Balloon AngioplastyDEVICE

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

Chocolate PTA Balloon
Standard PTA Balloon AngioplastyDEVICE

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

Standard PTA Balloon

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Case Medical Center

Cleveland, Ohio, 44106, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Study Officials

  • Sahil A Parikh, MD

    Harrington Heart and Vascular Institute University Hospitals Case Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2014

First Posted

September 11, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

March 19, 2015

Record last verified: 2015-03

Locations

US(2)