Peripheral Vascular DiseasesDIAMOND-PADNCT03455374
Diamondback in Peripheral Vascular Disease
A study testing Treatment with CSI atherectomy device in people with Peripheral Vascular Diseases and Critical Limb Ischemia, run by Arkansas Heart Hospital at 2 sites in United States.
Trial summary
This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System in patients with PAD (total occlusions or significant stenosis). Patients will be enrolled if they have claudication and/or critical limb ischemia, and identifiable PAD disease with moderate to severe calcification on Computer… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases, Critical Limb Ischemia
- What is being tested?
- Treatment with CSI atherectomy device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Aug 2017to 13 May 2019
- 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
- • Patient with lower extremity claudication and PAD due to significant SFA or below the knee stenosis (50%≤99%) or total occlusions (100%) that affects the quality of life despite medical therapy.
- Evidence of significant SFA or below the knee disease involving the most symptomatic limb by noninvasive vascular testing with the use of the following:
- ABI: <0.9 (If ABI>1.4, SFA systolic acceleration time should be > 140 milliseconds);
- TBI: <0.6;
- Computed Tomographic Angiography (CTA) confirming at least a 50% SFA stenosis with moderate to severe calcification; or
- Magnetic Resonance Angiography (MRA) confirming at least a 50% SFA or below the knee stenosis with moderate to severe calcification.
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- At least one patent, non-treated below the knee vessel.
- Male and female patients that are ≥ 18 years of age.
- Subject has been advised of the beneficial effects of smoking cessation and regular exercise but must not be in the process of changing their smoking status at the time of screening. Patients may resume or increase exercising as an effect of post procedurally improved lower limb perfusion.
- Peak Walking Time (PWT) limited only by claudication.
- Willingness to participate in the study, documented by signed, written informed consent.
Who cannot join
- • Planned amputation.
- Any planned/scheduled revascularization procedures ≤ 30 days after baseline procedure.
- Prior lower extremity revascularization ≤ 30 days before baseline procedure.
- The target lesion is an in-stent restenosis.
- Infra-popliteal disease involving the last remaining vessel.
- Patients with a creatinine clearance < 30mL/min.
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- Patients with known bleeding disorders.
- Patients with known active pathological bleeding.
- Patients with known hypersensitivity to acetylsalicylic acid, clopidogrel bisulfate, ticagrelor, Aspirin, or other antiplatelets/anticoagulants.
- Patients with known history of intracranial hemorrhage at any time, GI bleed in the past 6 months, or major surgery within the past 30 days.
- Patients with known ischemic stroke during the past 3 months.
- Patients with known severe liver disease.
- Patient with known history of congestive heart failure (CHF) with an LVEF of < 30%.
- Patients considered being at risk of bradycardic events unless treated with a permanent pacemaker.
- Female patients with known pregnancy, breast feeding, or intend to become pregnant during the study period (all female patients 55 years and younger, without a history of hysterectomy must have a pregnancy test prior to PPI at baseline and at 6 months).
- Concern for inability of the patient to comply with study procedures and/or follow up (e.g., alcohol or drug abuse).
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Arkansas Site Management Services LLC
Little Rock, Arkansas, 72211
About this study
Official title: Diamondback Atherectomy With OCT Visualization for Calcified PAD Lesions for Calcified Peripheral Vascular Disease Lesions
This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System in patients with PAD (total occlusions or significant stenosis). Patients will be enrolled if they have claudication and/or critical limb ischemia, and identifiable PAD disease with moderate to severe calcification on Computer Tomography Angiogram (PCA) or peripheral angiogram requiring percutaneous peripheral intervention (PPI).
Read the detailed description
Orbital atherectomy (OA) is one of the most commonly used modalities for the treatment of obstructive femoral-popliteal PAD, especially in patients with large and calcified atherosclerotic plaques, either as stand alone or with subsequent drug-coated balloon angioplasty or stent implantation. These atherectomy procedures were primarily guided by peripheral angiography which has significant resolution limitations in regards to the plaque morphology and characteristics such as extent of calcification, and how deep the cuts are made in the vessel wall.
Optical coherence tomography (OCT) has recently emerged as a novel imaging modality. OCT imaging has been used both in coronary as well as in peripheral circulation extensively with no significant device related adverse effects. Previous research has shown the feasibility and safety of OCT use for peripheral artery imaging and its use in plaque characterization. The hypothesis for this study is that; use of diamond back atherectomy device will lead to effective removal of plaque in moderate to heavily calcified arteries without damaging deep into the adventitia or EEL or the adjacent healthy vessel wall and thus will lead to a favorable vascular response during follow up.
- Being tested
- Treatment with CSI atherectomy device
- Medical subject headings
- Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with CSI atherectomy deviceDevice
Following peripheral angiography, patients with significant SFA or below the knee artery disease (≥ 50%) or total occlusions (100%) will have a baseline OCT imaging of the target vessel and the lesion be treated with proper size CSI burr. Repeat OCT imaging will be performed after CSI. Drug eluting balloon angioplasty may be performed in discretion of the operator. If DEB is used, a final OCT imaging will be performed to assess lesion expansion and possible dissections. Balloon sizing will be based on 1:1 vessel ratio with the length covering from minimally diseased distal segment to minimally diseased proximal segment. We will try to avoid use of stents.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with CSI atherectomy device | Experimental | removal of the plaque from vessel wall by optical coherence tomography Receives: Device: Treatment with CSI atherectomy device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in luminal area gain, measured in mm, in treated segment of the vessel wall
Luminal area gain in the treated segment of the vessel wall between pre-and post-atherectomy OCT images.
Measured: Baseline and 7 month
Secondary outcomes (6)
Atherectomy OCT Analysis-plaque volume
Changes in calcified total plaque volume as compare to baseline.
Measured: 0 and 7 months
Atherectomy OCT Analysis-fibrous tissue
Changes in fibrous tissue amount as compared to baseline
Measured: 0 and 7 months
Atherectomy OCT Analysis- new dissections
Number of new dissections present at 7 months as compare to baseline
Measured: 0 and 7 months
Atherectomy OCT Analysis-new injuries
Percentage of cross-sectional images with new injury to the adventitia or EEL as compared to baseline
Measured: 0 and 7 months
Atherectomy images Analysis-Luminal area loss
Change in Luminal area loss as measure by calcified plaque volume as well as by the presence of lipid and fibrous tissue as compared to baseline
Measured: 0 and 7 months
Atherectomy images Analysis-persistent dissections
Percentage of cross-sectional images with persistent dissections as compared to baseline
Measured: 0 and 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2018
- Study start8 Aug 2017
- Primary completion13 May 2019
- Study completion13 May 2019
Why it stopped: PI/Sponsor mutual agreement due to poor enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Vascular DiseasesStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arkansas Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Abbott Medical Devices
- Responsible party
- Sponsor
- Investigators
- Mehmet Cilingiroglu, MD, Principal investigator, Arkansas Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03455374
- Sponsor's protocol ID
- 20171653
- Acronym
- DIAMOND-PAD
- Status last verified
- Jun 2019
- First submitted
- 8 Feb 2018
- Last updated
- 27 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diamondback Atherectomy With OCT Visualization for Calcified PAD Lesions for Calcified Peripheral Vascular Disease Lesions
- ClinicalTrials.gov ID
- NCT03455374
- Acronym / sponsor ID
- DIAMOND-PAD / 20171653
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI/Sponsor mutual agreement due to poor enrollment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Arkansas Heart HospitalUniversity, hospital or other
- Collaborators
- Abbott Medical Devices
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 13 May 2019 (actual)
- Study completion
- 13 May 2019 (actual)
- First posted
- 6 Mar 2018 (actual)
- 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.
This is a prospective, nonrandomized, single-arm study using CSI Orbital Atherectomy System in patients with PAD (total occlusions or significant stenosis). Patients will be enrolled if they have claudication and/or critical limb ischemia, and identifiable PAD disease with moderate to severe calcification on Computer Tomography Angiogram (PCA) or peripheral angiogram requiring percutaneous peripheral intervention (PPI).
Detailed description
Orbital atherectomy (OA) is one of the most commonly used modalities for the treatment of obstructive femoral-popliteal PAD, especially in patients with large and calcified atherosclerotic plaques, either as stand alone or with subsequent drug-coated balloon angioplasty or stent implantation. These atherectomy procedures were primarily guided by peripheral angiography which has significant resolution limitations in regards to the plaque morphology and characteristics such as extent of calcification, and how deep the cuts are made in the vessel wall.
Optical coherence tomography (OCT) has recently emerged as a novel imaging modality. OCT imaging has been used both in coronary as well as in peripheral circulation extensively with no significant device related adverse effects. Previous research has shown the feasibility and safety of OCT use for peripheral artery imaging and its use in plaque characterization. The hypothesis for this study is that; use of diamond back atherectomy device will lead to effective removal of plaque in moderate to heavily calcified arteries without damaging deep into the adventitia or EEL or the adjacent healthy vessel wall and thus will lead to a favorable vascular response during follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective
| Arm | Type | Receives |
|---|---|---|
| Treatment with CSI atherectomy device | Experimental | Device: Treatment with CSI atherectomy deviceremoval of the plaque from vessel wall by optical coherence tomography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- • Patient with lower extremity claudication and PAD due to significant SFA or below the knee stenosis (50%≤99%) or total occlusions (100%) that affects the quality of life despite medical therapy.
Key exclusion criteria (16 listed)
- • Planned amputation.
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 |
|---|---|---|
| Treatment with CSI atherectomy deviceFollowing peripheral angiography, patients with significant SFA or below the knee artery disease (≥ 50%) or total occlusions (100%) will have a baseline OCT imaging of the target vessel and the lesion be treated with proper size CSI burr. Repeat OCT imaging will be performed after CSI. Drug eluting balloon angioplasty may be performed in discretion of the operator. If DEB is used, a final OCT imaging will be performed to assess lesion expansion and possible dissections. Balloon sizing will be based on 1:1 vessel ratio with the length covering from minimally diseased distal segment to minimally diseased proximal segment. We will try to avoid use of stents. | Device | Treatment with CSI atherectomy device |
Primary outcome
Change in luminal area gain, measured in mm, in treated segment of the vessel wall
Time frame: Baseline and 7 month
Luminal area gain in the treated segment of the vessel wall between pre-and post-atherectomy OCT images.
6 secondary outcomes
Atherectomy OCT Analysis-plaque volume
Time frame: 0 and 7 months
Atherectomy OCT Analysis-fibrous tissue
Time frame: 0 and 7 months
Atherectomy OCT Analysis- new dissections
Time frame: 0 and 7 months
Atherectomy OCT Analysis-new injuries
Time frame: 0 and 7 months
Atherectomy images Analysis-Luminal area loss
Time frame: 0 and 7 months
Atherectomy images Analysis-persistent dissections
Time frame: 0 and 7 months
Results and safety
The study was stopped early (reason given: PI/Sponsor mutual agreement due to poor enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2019.
- Individual participant dataSharing planned: No
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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.
Mehmet Cilingiroglu, MD principal investigator
Arkansas Heart Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with CSI atherectomy device in people with Peripheral Vascular Diseases and Critical Limb Ischemia, run by Arkansas Heart Hospital 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 11 inclusion and 16 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: stopped early, as of the sponsor's last update on 27 Jun 2019. 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 stopped early (reason given: PI/Sponsor mutual agreement due to poor enrollment). Results are not available in the source record.
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?
Change in luminal area gain, measured in mm, in treated segment of the vessel wall (time frame: Baseline and 7 month). 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 27 Jun 2019.