Complete Lesion Assessment With ffR and IVUS TechnologY

NCT01941030 | Completed Results

• 1 other identifier: CLARITY I
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 8

Brief 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).

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)

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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.

  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.

  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.

  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.

  Pre-intervention, and post-balloon angioplasty

Secondary Outcomes (1)

• Fractional Flow Reserve

  Post-orbital atherectomy (OA arm only) and post-balloon angioplasty (both arms)

Study Arms (2)

Orbital Atherectomy System

EXPERIMENTAL

Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)

Device: Orbital Atherectomy System; Device: Balloon Angioplasty

Balloon Angioplasty

ACTIVE COMPARATOR

Balloon Angioplasty (BA) alone

Device: Balloon Angioplasty

Interventions

Orbital Atherectomy System DEVICE

Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)

Orbital Atherectomy System

Balloon Angioplasty DEVICE

Type of balloon selected is driven by preference of the operator.

Balloon Angioplasty; Orbital Atherectomy System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (8)

Arkansas Heart Clinic

Little Rock, Arkansas, 72211, United States

Location

Northside Hospital

Atlanta, Georgia, 30342, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

Mission Research Institute

New Braunfels, Texas, 78130, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia

Interventions

Angioplasty, Balloon

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Intervention Hierarchy (Ancestors)

Angioplasty; Catheterization; Therapeutics; Endovascular Procedures; Vascular Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Investigative Techniques

Limitations and Caveats

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

Results Point of Contact

• Title: Clinical Trials Manager
• Organization: Cardiovascular Systems, Inc.

clinicaltrials_csi@csi360.com

651.259.2500

Study Officials

• Raymond Dattilo, M.D.

  St. Francis Heart and Vascular Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

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: March 11, 2013
• First Posted: September 13, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: June 1, 2015
• Last Updated: July 18, 2023
• Results First Posted: January 24, 2019

Record last verified: 2023-07

Locations

US (8)