CompletedNCT01941030CLARITY IUpdated Jul 18, 2023Results posted

Complete Lesion Assessment With ffR and IVUS TechnologY

An interventional study of Orbital Atherectomy System and Balloon Angioplasty in Peripheral Artery Disease and Critical Limb Ischemia, sponsored by Abbott Medical Devices. Completed at 8 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-18.

Sponsored by Abbott Medical Devices · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 51
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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 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 studied

Peripheral Artery Disease
Critical Limb Ischemia

Browse trials for

Keywords

Peripheral Artery Disease
Critical Limb Ischemia
Orbital Atherectomy
Balloon Angioplasty
Intravascular Ultrasound (IVUS)
Fractional Flow Reserve (FFR)

In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 51 is below the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Abbott Medical Devices is the lead sponsor of 525 studies on the registry; 35 are open to participants now.

Of its 52 completed or terminated interventional studies of FDA-regulated products, 43 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 51 participants (actual)

Study arms

Experimental
Orbital Atherectomy System
Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)
Device: Orbital Atherectomy System · Device: Balloon Angioplasty
Active comparator
Balloon Angioplasty
Balloon Angioplasty (BA) alone
Device: Balloon Angioplasty

Interventions

DeviceOrbital Atherectomy System
Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
DeviceBalloon Angioplasty
Type of balloon selected is driven by preference of the operator.

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Pre-intervention, and post-balloon angioplasty

Secondary outcomes

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

Results

Posted Jan 24, 2019

Limitations and caveats

CLARITY I was a non-powered trial without a hypothesis test of a small number of patients.

Participant flow

Participant flow — Overall Study
Milestone	Orbital Atherectomy System	Balloon Angioplasty
Started	25	26
Completed	12	13
Not completed	13	13
Withdrew: Death	3	2
Withdrew: Lost to follow-up	6	5
Withdrew: Withdrawal by subject	4	6

Outcome measures

PrimaryPercentage 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.

Time frame:: Post-balloon angioplasty
Reported as:: Median · percentage of lumen gain

Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS
percentage of lumen gain	Orbital Atherectomy System	Balloon Angioplasty
Percentage of Calcium Removal Out of Lumen Gain as Assessed by IVUS	25.0 (11.1 to 42.9)	0.0 (0.0 to 6.7)

Statistical analysis

Orbital Atherectomy System vs Balloon Angioplasty · Wilcoxon (Mann-Whitney) · p = 0.0220Data failed to meet the assumption for normality per the Shapiro-Wilk test.

PrimaryChange 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.

Time frame:: Pre-intervention, and post-balloon angioplasty
Reported as:: Median · percent of minimum area stenosis

Change in Minimum Lumen Area Percent Stenosis as Assessed by IVUS
percent of minimum area stenosis	Orbital Atherectomy System	Balloon Angioplasty
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)

Statistical analysis

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

PrimaryChange 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.

Time frame:: Pre-intervention, and post-balloon angioplasty
Reported as:: Median · area (mm^3/mm)

Change in Plaque Area as Assessed by IVUS
area (mm^3/mm)	Orbital Atherectomy System	Balloon Angioplasty
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)

Statistical analysis

Orbital Atherectomy System vs Balloon Angioplasty · Wilcoxon (Mann-Whitney) · p = 0.4528Data failed to meet the assumption for normality per the Shapiro-Wilk test.

PrimaryChange 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.

Time frame:: Pre-intervention, and post-balloon angioplasty
Reported as:: Median · area (mm^3/mm)

Change in Dense Calcium Area as Assessed by IVUS
area (mm^3/mm)	Orbital Atherectomy System	Balloon Angioplasty
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)

Statistical analysis

Orbital Atherectomy System vs Balloon Angioplasty · Wilcoxon (Mann-Whitney) · p = 0.3573Data failed to meet the assumption for normality per the Shapiro-Wilk test.

PrimaryChange 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.

Time frame:: Pre-intervention, and post-balloon angioplasty
Reported as:: Median · area (mm^3/mm)

Change in Necrotic Core Area as Assessed by IVUS
area (mm^3/mm)	Orbital Atherectomy System	Balloon Angioplasty
Pre-Tx, necrotic core area (mm^3/mm)	0.7 (0.4 to 1.2)	0.9 (0.4 to 1.2)
Post-Tx, necrotic core area (mm^3/mm)	0.8 (0.3 to 1.0)	1.0 (0.5 to 1.1)

Statistical analysis

Orbital Atherectomy System vs Balloon Angioplasty · Wilcoxon (Mann-Whitney) · p = 0.6073Data failed to meet the assumption for normality per the Shapiro-Wilk test.

PrimaryChange 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.

Time frame:: Pre-intervention, and post-balloon angioplasty
Reported as:: Median · area (mm^3/mm)

Change in Fibrous Plaque Area as Assessed by IVUS
area (mm^3/mm)	Orbital Atherectomy System	Balloon Angioplasty
Pre-Tx, fibrous plaque area (mm^3/mm)	1.7 (0.9 to 2.6)	1.0 (0.6 to 2.0)
Post-Tx, fibrous plaque area (mm^3/mm)	1.4 (0.9 to 3.3)	0.9 (0.8 to 1.6)

Statistical analysis

Orbital Atherectomy System vs Balloon Angioplasty · Wilcoxon (Mann-Whitney) · p = 0.2149Data failed to meet the assumption for normality per the Shapiro-Wilk test.

PrimaryChange 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.

Time frame:: Pre-intervention, and post-balloon angioplasty
Reported as:: Median · area (mm^3/mm)

Change in Fibrofatty Plaque Area as Assessed by IVUS
area (mm^3/mm)	Orbital Atherectomy System	Balloon Angioplasty
Pre-Tx, fibrofatty plaque area (mm^3/mm)	0.2 (0.1 to 0.7)	0.1 (0.0 to 0.3)
Post-Tx, fibrofatty plaque area (mm^3/mm)	0.2 (0.1 to 1.0)	0.1 (0.0 to 0.1)

Statistical analysis

Orbital Atherectomy System vs Balloon Angioplasty · Wilcoxon (Mann-Whitney) · p = 0.0579Data failed to meet the assumption for normality per the Shapiro-Wilk test.

SecondaryFractional 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.

Time frame:: Post-orbital atherectomy (OA arm only) and post-balloon angioplasty (both arms)
Reported as:: Mean · Ratio (proximal/distal pressure)

Fractional Flow Reserve
Ratio (proximal/distal pressure)	Orbital Atherectomy System	Balloon Angioplasty
Post final OAS: FFR w/ 600 mcg adenosine	0.83 ± 0.14	NA ± NA
Post final OAS: FFR with 1200 mcg adenosine	0.80 ± 0.12	NA ± NA
Post final balloon: FFR w/ 600 mcg adenosine	0.90 ± 0.13	0.75 ± 0.22
Post final balloon: FFR w/ 1200 mcg adenosine	0.87 ± 0.10	0.76 ± 0.24

Statistical analysis

Orbital Atherectomy System vs Balloon Angioplasty · t-test, 2 sided · p = 0.076
Orbital Atherectomy System vs Balloon Angioplasty · t-test, 2 sided · p = 0.205

Adverse events

Collected over AEs were collected during the index-procedure through 12 months of follow-up.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Orbital Atherectomy System	3/25 (12%)	22/25 (88%)	4/25 (16%)
Balloon Angioplasty	3/26 (11.5%)	17/26 (65.4%)	8/26 (30.8%)

Most frequent serious events

Showing 10 of 40

Most frequent serious events
Event	Orbital Atherectomy System	Balloon Angioplasty
Revascularization, non-index limbSurgical and medical procedures	4/25	2/26
Minor amputation - pre-planned, index limbSurgical and medical procedures	2/25	4/26
Revascularization, index limb (TLR)Surgical and medical procedures	3/25	3/26
RecoilInjury, poisoning and procedural complications	0/25	3/26
Revascularization, index limb (non-TVR)Surgical and medical procedures	1/25	3/26
Congestive Heart FailureCardiac disorders	2/25	2/26
Death, unknown causeGeneral disorders	2/25	1/26
Major amputation, index limb due to gangreneSurgical and medical procedures	2/25	1/26
Minor amputation, index limb due to gangreneSurgical and medical procedures	2/25	2/26
Respiratory failureRespiratory, thoracic and mediastinal disorders	2/25	0/26

Most frequent other events

Most frequent other events
Event	Orbital Atherectomy System	Balloon Angioplasty
DissectionInjury, poisoning and procedural complications	1/25	5/26
Vessel spasmInjury, poisoning and procedural complications	3/25	0/26
Access site bleedingInjury, poisoning and procedural complications	0/25	1/26
Lower extremity edemaGeneral disorders	0/25	1/26
Pseudoaneurysm, access siteInjury, poisoning and procedural complications	0/25	1/26
Slow flowInjury, poisoning and procedural complications	0/25	1/26
Urinary tract infectionRenal and urinary disorders	0/25	1/26

Baseline characteristics

Age, Continuous
Age, Continuous(years)	Orbital Atherectomy System	Balloon Angioplasty	Total
Mean	65.3 ± 11.3	69.4 ± 12.4	67.4 ± 11.9

Sex: Female, Male
Sex: Female, Male(Participants)	Orbital Atherectomy System	Balloon Angioplasty	Total
Female	3	12	15
Male	22	14	36

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Orbital Atherectomy System	Balloon Angioplasty	Total
Hispanic or Latino	6	3	9
Not Hispanic or Latino	19	23	42
Unknown or Not Reported	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Orbital Atherectomy System	Balloon Angioplasty	Total
American Indian or Alaska Native	0	0	0
Asian	0	0	0
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	8	8	16
White	17	18	35
More than one race	0	0	0
Unknown or Not Reported	0	0	0

Region of Enrollment
Region of Enrollment(participants)	Orbital Atherectomy System	Balloon Angioplasty	Total
United States	25	26	51

Number of treated lesions
Number of treated lesions(lesions)	Orbital Atherectomy System	Balloon Angioplasty	Total
Number	26	26	52

Study locations

8 sites

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

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01941030
Lead sponsor: Abbott Medical Devices
Responsible party: Sponsor
First posted: Sep 13, 2013
Start date: Mar 2013
Primary completion: Jun 2015
Completion: Jun 2015
Results posted: Jan 24, 2019
Last update: Jul 18, 2023

Study contacts

Raymond Dattilo, M.D.

principal investigator · St. Francis Heart and Vascular Center

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Peripheral Arterial Disease→

Other studies from this sponsor

Abbott Medical Devices

Start the discussion