Peripheral Artery DiseaseCLARITY INCT01941030

Complete Lesion Assessment With ffR and IVUS TechnologY

A study testing Orbital Atherectomy System and Balloon Angioplasty in people with Peripheral Artery Disease and Critical Limb Ischemia, run by Abbott Medical Devices at 8 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Artery Disease, Critical Limb Ischemia
What is being tested?: Orbital Atherectomy System and Balloon Angioplasty
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 51 participants
Where: 8 sitesUnited States
Study dates: Mar 2013to Jun 2015
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

General Inclusion Criteria:

Subject's age ≥ 18 years.
Subject is an acceptable candidate for percutaneous intervention with the Sponsor's OAS and BA in accordance with their labeled indications and instructions for use.
Subject is willing and able to sign an approved informed consent form (ICF).
Subject is willing and able to attend follow-up and wound care visits.

General Exclusion Criteria:

Subject is pregnant or planning to become pregnant within the study period.
Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this trial.
Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated.
Uncontrolled allergy to nitinol, stainless steel, or other stent materials.
Subject has known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide.
Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
Subject has been diagnosed with chronic renal failure or has a creatinine level > 2.5, unless on dialysis, prior to the index treatment.
Subject has evidence of intracranial or gastrointestinal bleeding within 90 days.
Subject has a history of trauma, fracture, major surgery (includes major amputation), or biopsy of a parenchymal organ within past 14 days, or patient has not healed from a previous medical intervention occurring more than 14 days.
Subject has a history of stroke or myocardial infarction (MI) within 90 days prior to enrollment in the study.
Subject has a planned major surgery (includes major amputation) scheduled within 60 days after treatment of the index limb.
Subject has a planned interventional treatment to address stenosis of the contralateral limb scheduled within 60 days after the index treatment.
Subject has a planned interventional treatment to address inflow stenosis of the ipsilateral limb scheduled within 60 days after the index treatment.
Inflow or bilateral PAD requiring treatment prior to enrollment was not successfully treated, defined as > 50% residual stenosis and/or occurrence of procedural angiographic complications, excluding dissection types A and B.
Subject has previously had their other limb treated as part of the study.

Angiographic Inclusion Criteria:

Target lesion(s) located in the anterior tibial (AT), posterior tibial (PT), tibial peroneal trunk (TPT) or peroneal (PR) arteries.
Target lesion has ≥ 50 % stenosis by angiography.
Subject has a corresponding wound being fed by the target vessel.

Angiographic Exclusion Criteria:

Target limb does not have any visual flow to the foot confirmed via distal selective angiography.
Thrombus is present or suspected in the target treatment vessel.
Target lesion is within a bypass graft or near a previously placed stent.
The guide wire cannot be passed across the target lesion.
Anterograde access of the lesion is not possible.
Subject has angiographic evidence of significant dissection at or near the treatment site.
Interventional treatment is intended for in-stent restenosis at the peripheral vascular site.
Subject's wound(s) involve multiple angiosomes.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Northside Hospital
Atlanta, Georgia, 30342
Midwest Cardiovascular Research Foundation
Davenport, Iowa, 52803
St. John Hospital and Medical Center
Detroit, Michigan, 48236
Arkansas Heart Clinic
Little Rock, Arkansas, 72211
Mission Research Institute
New Braunfels, Texas, 78130
Sentara Vascular Specialists
Norfolk, Virginia, 23507
Rex Hospital
Raleigh, North Carolina, 27607
Holy Name Medical Center
Teaneck, New Jersey, 07666

Other trials in United States

About this study

Official title: Complete Lesion Assessment With ffR and IVUS TechnologY (CLARITY I)

CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).

Read the detailed description

This prospective, randomized, multi-center, post-market study of approximately 50 subjects randomized 1:1 to Orbital Atherectomy (OA) performed with Cardiovascular Systems, Inc.'s Orbital Atherectomy System (OAS) followed by adjunctive balloon angioplasty (BA) vs. BA alone for treatment of tibial vessel disease, defined as ≥ 50 % stenosis of the anterior tibial (AT), posterior tibial (PT), tibial peroneal trunk (TPT), or peroneal (PR) arteries by angiography. All subjects will have a corresponding wound being fed by the target vessel which will be assessed during the study. Subjects will be followed to one year.

Conditions: Peripheral Artery Disease, Critical Limb Ischemia
Being tested: Orbital Atherectomy System, Balloon Angioplasty
Keywords: Peripheral Artery Disease, Critical Limb Ischemia, Orbital Atherectomy, Balloon Angioplasty, Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR)
Medical subject headings: Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Orbital Atherectomy SystemDevice
Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
Balloon AngioplastyDevice
Type of balloon selected is driven by preference of the operator.

Study groups in NCT01941030
Study group	Role	What they receive
Orbital Atherectomy System	Experimental	Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA) Receives: Device: Orbital Atherectomy System; Device: Balloon Angioplasty
Balloon Angioplasty	Active comparator	Balloon Angioplasty (BA) alone Receives: Device: Balloon Angioplasty

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS
The post-treatment percentage of calcium removal out of lumen gain at the maximum calcium ablation site. A positive value equates to reduction in calcium out of the lumen gain.
Measured: Post-balloon angioplasty
Change in Minimum Lumen Area Percent Stenosis as Assessed by IVUS
The pre- (Pre-Tx) and post-treatment (Post-Tx) minimum lumen area percent stenosis. A positive value equates to a decrease in lumen area percent stenosis.
Measured: Pre-intervention, and post-balloon angioplasty
Change in Plaque Area as Assessed by IVUS
The pre- (Pre-Tx) and post-treatment (Post-Tx) plaque area. A positive value equates to a decrease in plaque area.
Measured: Pre-intervention, and post-balloon angioplasty
Change in Dense Calcium Area as Assessed by IVUS
The pre- (Pre-Tx) and post-treatment (Post-Tx) dense calcium area. A positive value equates to a decrease in dense calcium area.
Measured: Pre-intervention, and post-balloon angioplasty
Change in Necrotic Core Area as Assessed by IVUS
The pre- (Pre-Tx) and post-treatment (Post-Tx) necrotic core area. A positive value equates to a decrease necrotic core area.
Measured: Pre-intervention, and post-balloon angioplasty
Change in Fibrous Plaque Area as Assessed by IVUS
The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrous plaque area. A positive value equates to a decrease in fibrous plaque area.
Measured: Pre-intervention, and post-balloon angioplasty
Change in Fibrofatty Plaque Area as Assessed by IVUS
The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrofatty plaque area. A positive value equates to a decrease in fibrofatty plaque area.
Measured: Pre-intervention, and post-balloon angioplasty

Secondary outcomes (1)

Fractional Flow Reserve
Fractional flow reserve (FFR) will be measured to assess hemodynamic function following each device procedure. During FFR, adenosine will be given through the femoral artery sheath or access catheter in two doses: 600 mcg and 1200 mcg. A higher FFR is presumed to correlate to better flow which may improve wound healing.
Measured: Post-orbital atherectomy (OA arm only) and post-balloon angioplasty (both arms)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Jun 2015

First posted13 Sep 2013 (estimated)
Study startMar 2013
Primary completionJun 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
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: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01941030
Sponsor's protocol ID: CLARITY I
Acronym: CLARITY I
Status last verified: Jul 2023
First submitted: 11 Mar 2013
Last updated: 18 Jul 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Peripheral Artery Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Complete Lesion Assessment With ffR and IVUS TechnologY (CLARITY I)
ClinicalTrials.gov ID: NCT01941030
Acronym / sponsor ID: CLARITY I / CLARITY I
Conditions: Peripheral Artery Disease, Critical Limb Ischemia
Keywords: Peripheral Artery Disease, Critical Limb Ischemia, Orbital Atherectomy, Balloon Angioplasty, Intravascular Ultrasound (IVUS), Fractional Flow Reserve (FFR)
Study type: Interventional
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: Abbott Medical DevicesIndustry (pharma, biotech, devices)
Study start: Mar 2013
Primary completion: Jun 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 13 Sep 2013 (estimated)
Results: Posted 24 Jan 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

CLARITY I is a pilot study to identify the clinically appropriate endpoint(s) of a larger, statistically powered pivotal trial for treatment of patients with Critical Limb Ischemia (CLI).

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Orbital Atherectomy System	Experimental	Device: Orbital Atherectomy System, Device: Balloon AngioplastyOrbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Balloon Angioplasty	Active comparator	Device: Balloon AngioplastyBalloon Angioplasty (BA) alone

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

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
Orbital Atherectomy SystemOrbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)	Device	Orbital Atherectomy System
Balloon AngioplastyType of balloon selected is driven by preference of the operator.	Device	Balloon Angioplasty, Orbital Atherectomy System

Primary outcome

Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS
Time frame: Post-balloon angioplasty
The post-treatment percentage of calcium removal out of lumen gain at the maximum calcium ablation site. A positive value equates to reduction in calcium out of the lumen gain.
Change in Minimum Lumen Area Percent Stenosis as Assessed by IVUS
Time frame: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) minimum lumen area percent stenosis. A positive value equates to a decrease in lumen area percent stenosis.
Change in Plaque Area as Assessed by IVUS
Time frame: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) plaque area. A positive value equates to a decrease in plaque area.
Change in Dense Calcium Area as Assessed by IVUS
Time frame: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) dense calcium area. A positive value equates to a decrease in dense calcium area.
Change in Necrotic Core Area as Assessed by IVUS
Time frame: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) necrotic core area. A positive value equates to a decrease necrotic core area.
Change in Fibrous Plaque Area as Assessed by IVUS
Time frame: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrous plaque area. A positive value equates to a decrease in fibrous plaque area.
Change in Fibrofatty Plaque Area as Assessed by IVUS
Time frame: Pre-intervention, and post-balloon angioplasty
The pre- (Pre-Tx) and post-treatment (Post-Tx) fibrofatty plaque area. A positive value equates to a decrease in fibrofatty plaque area.

1 secondary outcome

Fractional Flow Reserve
Time frame: Post-orbital atherectomy (OA arm only) and post-balloon angioplasty (both arms)

Results and safety

Results posted to the registry on 24 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Orbital Atherectomy System	25	12
Balloon Angioplasty	26	13

Primary outcome: Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS

Time frame: Post-balloon angioplasty. Median (Inter-Quartile Range). Unit: percentage of lumen gain

Measure	Orbital Atherectomy System n = 25	Balloon Angioplasty n = 26
Value	25.0 (11.1 to 42.9)	0.0 (0.0 to 6.7)

Orbital Atherectomy System vs Balloon Angioplasty: p = 0.0220, Wilcoxon (Mann-Whitney)

Population analysed: Not all subjects had reported IVUS data for each lesion pre- and post-treatment.

Primary outcome: Change in Minimum Lumen Area Percent Stenosis as Assessed by IVUS

Time frame: Pre-intervention, and post-balloon angioplasty. Median (Inter-Quartile Range). Unit: percent of minimum area stenosis

Measure	Orbital Atherectomy System n = 25	Balloon Angioplasty n = 26
Pre-Tx, minimum area stenosis (%)	43.8 (37.6 to 62.4)	45.2 (34.5 to 58.5)
Post-Tx, minimum area stenosis (%)	36.4 (29.0 to 51.5)	31.5 (26.5 to 45.2)

Orbital Atherectomy System vs Balloon Angioplasty: p = 0.6228, t-test, 2 sided

Population analysed: Not all subjects had reported IVUS data for each lesion pre- and post-treatment.

Primary outcome: Change in Plaque Area as Assessed by IVUS

Time frame: Pre-intervention, and post-balloon angioplasty. Median (Inter-Quartile Range). Unit: area (mm^3/mm)

Measure	Orbital Atherectomy System n = 25	Balloon Angioplasty n = 26
Pre-Tx, plaque area (mm^3/mm)	6.5 (4.7 to 8.2)	6.0 (4.9 to 6.5)
Post-Tx, plaque area (mm^3/mm)	6.3 (4.4 to 10.0)	6.0 (5.6 to 7.1)

Orbital Atherectomy System vs Balloon Angioplasty: p = 0.4528, Wilcoxon (Mann-Whitney)

Population analysed: Not all subjects had reported IVUS data for each lesion pre- and post-treatment.

Primary outcome: Change in Dense Calcium Area as Assessed by IVUS

Time frame: Pre-intervention, and post-balloon angioplasty. Median (Inter-Quartile Range). Unit: area (mm^3/mm)

Measure	Orbital Atherectomy System n = 25	Balloon Angioplasty n = 26
Pre-Tx, dense calcium area (mm^3/mm)	0.7 (0.2 to 1.5)	1.0 (0.2 to 1.4)
Post-Tx, dense calcium area (mm^3/mm)	0.4 (0.2 to 1.2)	1.1 (0.2 to 1.7)

Orbital Atherectomy System vs Balloon Angioplasty: p = 0.3573, Wilcoxon (Mann-Whitney)

Population analysed: Not all subjects had reported IVUS data for each lesion pre- and post-treatment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: AEs were collected during the index-procedure through 12 months of follow-up.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Orbital Atherectomy System	22 of 25 (88%)	4 of 25 (16%)	3 of 25
Balloon Angioplasty	17 of 26 (65.4%)	8 of 26 (30.8%)	3 of 26

Limitations and caveats (from the sponsor): CLARITY I was a non-powered trial without a hypothesis test of a small number of patients.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Raymond Dattilo, M.D. principal investigator

St. Francis Heart and Vascular Center

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Orbital Atherectomy System and Balloon Angioplasty in people with Peripheral Artery Disease and Critical Limb Ischemia, run by Abbott Medical Devices at 8 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?

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: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 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?

Yes. Results are posted in the registry (first posted 24 Jan 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS (time frame: Post-balloon angioplasty). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01941030.

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 18 Jul 2023.