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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01941030
First Posted: September 13, 2013
Last Update Posted: August 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Cardiovascular Systems Inc
  Purpose
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).

Condition Intervention
Peripheral Artery Disease Critical Limb Ischemia Device: Orbital Atherectomy System Device: Balloon Angioplasty

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Complete Lesion Assessment With ffR and IVUS TechnologY (CLARITY I)

Resource links provided by NLM:


Further study details as provided by Cardiovascular Systems Inc:

Primary Outcome Measures:
  • Change in Plaque Volume and Composition via IVUS [ Time Frame: Pre-intervention, and post-balloon angioplasty ]
    The pre- and post-treatment vessel size and plaque volume/composition in both study arms will be assessed via independent review of the IVUS images collected during the study by the IVUS Core Lab. The plaque burden will be broken down into the contributing percentages of each of the our primary plaque components: Fibrotic, Fibrofatty, Necrotic core, Dense calcium.


Secondary Outcome Measures:
  • Fractional Flow Reserve [ Time Frame: Post-orbital atherectomy (OA arm only) and post-balloon angioplasty (both arms) ]
    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 to determine the optimal hyperemic dose. A higher FFR is presumed to correlate to better flow which may improve wound healing. Some sites may be exempt from performing FFR.


Enrollment: 51
Study Start Date: March 2013
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01941030


Locations
United States, Arkansas
Arkansas Heart Clinic
Little Rock, Arkansas, United States, 72211
United States, Georgia
Northside Hospital
Atlanta, Georgia, United States, 30342
United States, Iowa
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States, 52803
United States, Michigan
St. John Hospital and Medical Center
Detroit, Michigan, United States, 48236
United States, New Jersey
Holy Name Medical Center
Teaneck, New Jersey, United States, 07666
United States, North Carolina
Rex Hospital
Raleigh, North Carolina, United States, 27607
United States, Texas
Mission Research Institute
New Braunfels, Texas, United States, 78130
United States, Virginia
Sentara Vascular Specialists
Norfolk, Virginia, United States, 23507
Sponsors and Collaborators
Cardiovascular Systems Inc
Investigators
Principal Investigator: Raymond Dattilo, M.D. St. Francis Heart and Vascular Center
  More Information

Responsible Party: Cardiovascular Systems Inc
ClinicalTrials.gov Identifier: NCT01941030     History of Changes
Other Study ID Numbers: CLARITY I
First Submitted: March 11, 2013
First Posted: September 13, 2013
Last Update Posted: August 7, 2017
Last Verified: August 2017

Keywords provided by Cardiovascular Systems Inc:
Peripheral Artery Disease
Critical Limb Ischemia
Orbital Atherectomy
Balloon Angioplasty
Intravascular Ultrasound (IVUS)
Fractional Flow Reserve (FFR)

Additional relevant MeSH terms:
Ischemia
Peripheral Arterial Disease
Pathologic Processes
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases