Infrainguinal Peripheral Arterial DiseaseNCT02237066
Understanding Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging
A study testing Chocolate PTA Balloon Angioplasty and Standard PTA Balloon Angioplasty in people with Infrainguinal Peripheral Arterial Disease, run by TriReme Medical, LLC at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infrainguinal Peripheral Arterial Disease
- What is being tested?
- Chocolate PTA Balloon Angioplasty and Standard PTA Balloon Angioplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2014to Mar 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Case Medical Center
Cleveland, Ohio, 44106
Cleveland Clinic
Cleveland, Ohio, 44195
About this study
Official title: 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.
Read the 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.
- Being tested
- Chocolate PTA Balloon Angioplasty, Standard PTA Balloon Angioplasty
- Keywords
- OCT, PTA, Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
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
| Study group | Role | What they receive |
|---|---|---|
| Chocolate PTA Balloon | Experimental | Chocolate PTA Balloon Angioplasty Receives: Device: Chocolate PTA Balloon Angioplasty |
| Standard PTA Balloon | Active comparator | Standard PTA Balloon Angioplasty Receives: Device: Standard PTA Balloon Angioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Average of 90 minutes
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Average of 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2015 (estimated)
Why it stopped: Enrollment goals were not able to be met
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infrainguinal Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriReme Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center
- Responsible party
- Sponsor
- Investigators
- Sahil A Parikh, MD, Principal investigator, Harrington Heart and Vascular Institute University Hospitals Case Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02237066
- Sponsor's protocol ID
- Chocolate OCT
- Status last verified
- Mar 2015
- First submitted
- 3 Sep 2014
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Mechanism of Peripheral Arterial Balloon Angioplasty by the Chocolate PTA Balloon Catheter Compared to Conventional PTA Balloons Via OCT Imaging
- ClinicalTrials.gov ID
- NCT02237066
- Acronym / sponsor ID
- Chocolate OCT
- Keywords
- OCT, PTA, Balloon
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment goals were not able to be met
- Enrolment
- 0 participants (actual)
- Lead sponsor
- TriReme Medical, LLCIndustry (pharma, biotech, devices)
- Collaborators
- University Hospitals Cleveland Medical Center
- Study start
- Sep 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 11 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chocolate PTA Balloon | Experimental | Device: Chocolate PTA Balloon AngioplastyChocolate PTA Balloon Angioplasty |
| Standard PTA Balloon | Active comparator | Device: Standard PTA Balloon AngioplastyStandard PTA Balloon Angioplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chocolate PTA Balloon AngioplastyOCT 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 | Device | Chocolate PTA Balloon |
| Standard PTA Balloon AngioplastyOCT 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 | Device | Standard PTA Balloon |
Primary outcome
Luminal Gain
Time frame: 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).
3 secondary outcomes
Dissection
Time frame: Average of 90 minutes
Hematoma
Time frame: Average of 90 minutes
Optimal PTA
Time frame: Average of 90 minutes
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sahil A Parikh, MD principal investigator
Harrington Heart and Vascular Institute University Hospitals Case Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chocolate PTA Balloon Angioplasty and Standard PTA Balloon Angioplasty in people with Infrainguinal Peripheral Arterial Disease, run by TriReme Medical, LLC at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Luminal Gain (time frame: Average of 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2015.