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

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).

Study Overview

• Status: Completed
• Conditions: Peripheral Artery Disease; Critical Limb Ischemia
• Intervention / Treatment: Device: Orbital Atherectomy System; Device: Balloon Angioplasty

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.

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

General Inclusion Criteria:

1. Subject's age ≥ 18 years.
2. 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.
3. Subject is willing and able to sign an approved informed consent form (ICF).
4. Subject is willing and able to attend follow-up and wound care visits.

General Exclusion Criteria:

1. Subject is pregnant or planning to become pregnant within the study period.
2. Subject is currently participating in an investigational drug or other device study that can clinically interfere with the endpoints of this trial.
3. Subject has a known sensitivity to contrast media and the sensitivity cannot be adequately pre-medicated.
4. Uncontrolled allergy to nitinol, stainless steel, or other stent materials.
5. Subject has known allergy to atherectomy lubricant components such as soybean oil, egg yolk phospholipids, glycerin or sodium hydroxide.
6. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood transfusions.
7. Subject has been diagnosed with chronic renal failure or has a creatinine level > 2.5, unless on dialysis, prior to the index treatment.
8. Subject has evidence of intracranial or gastrointestinal bleeding within 90 days.
9. 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.
10. Subject has a history of stroke or myocardial infarction (MI) within 90 days prior to enrollment in the study.
11. Subject has a planned major surgery (includes major amputation) scheduled within 60 days after treatment of the index limb.
12. Subject has a planned interventional treatment to address stenosis of the contralateral limb scheduled within 60 days after the index treatment.
13. Subject has a planned interventional treatment to address inflow stenosis of the ipsilateral limb scheduled within 60 days after the index treatment.
14. 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.
15. Subject has previously had their other limb treated as part of the study.

Angiographic Inclusion Criteria:

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

Angiographic Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Orbital Atherectomy System; Orbital Atherectomy (OA) is performed prior to adjunctive Balloon Angioplasty (BA)	Device: Orbital Atherectomy System; Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA); Device: Balloon Angioplasty; Type of balloon selected is driven by preference of the operator.
Active Comparator: Balloon Angioplasty; Balloon Angioplasty (BA) alone	Device: Balloon Angioplasty; Type of balloon selected is driven by preference of the operator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Post-orbital atherectomy (OA arm only) and post-balloon angioplasty (both arms)

Collaborators and Investigators

• Sponsor: Abbott Medical Devices
• Investigators: Principal Investigator: Raymond Dattilo, M.D., St. Francis Heart and Vascular Center

Study record dates

Study Major Dates

• Study Start: March 1, 2013
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: March 11, 2013
• First Submitted That Met QC Criteria: September 9, 2013
• First Posted (Estimated): September 13, 2013

Study Record Updates

• Last Update Posted (Actual): July 18, 2023
• Last Update Submitted That Met QC Criteria: July 14, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; Fractional Flow Reserve (FFR); Orbital Atherectomy; Balloon Angioplasty; Intravascular Ultrasound (IVUS); Critical Limb Ischemia
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Disease Attributes; Atherosclerosis; Peripheral Vascular Diseases; Chronic Disease; Ischemia; Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia
• Other Study ID Numbers: CLARITY I