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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Cardiovascular Systems Inc
ClinicalTrials.gov Identifier:
NCT01941030
First received: March 11, 2013
Last updated: June 26, 2014
Last verified: June 2014
  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: 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:
  • Rate of Major Adverse Events (MAEs) [ Time Frame: 6 months followup and 12 months followup ] [ Designated as safety issue: Yes ]
    MAE's are defined for the study as death, major unplanned amputation (above the ankle) of the index limb, and clinically-driven target vessel revascularization (TLR). MAE's will be collected through 6 months and 12 months post-treatment with the study devices.


Secondary Outcome Measures:
  • Procedural Parameters [ Time Frame: Post-orbital atherectomy (OA arm only) and post-balloon angioplasty ] [ Designated as safety issue: No ]
    Maximum balloon inflation pressure (atm) and time at maximum pressure (sec), rate of stenting, and rate of procedural angiographic complications (dissection, perforation, and distal embolization) will be compared between the two study arms. Angiography will be assessed by an independent Angio Core Lab.

  • Technical Success [ Time Frame: Post-orbital atherectomy (OA arm only) and post-balloon angioplasty ] [ Designated as safety issue: No ]
    Technical success is defined for each arm as a final post-procedure result of < 50% residual stenosis by angiography (before stenting, if performed). Angiography will be assessed by an independent Angio Core Lab.


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated 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
Balloon selection is driven by preference of the operator.
Active Comparator: Balloon Angioplasty
Balloon Angioplasty (BA) alone
Device: Balloon Angioplasty
Balloon selection is driven by preference of the operator.

Detailed Description:

50 subjects will be 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 tibial arteries (AT, PT, TPT, and PR) by angiography. All subjects will have a corresponding wound being fed by the target vessel which will be assessed during the study. Subjects enrolled in this study may be rolled into the larger pivotal trial, as appropriate.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 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.
  • Subject has previously had their other limb treated as part of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Cardiovascular Systems Inc
ClinicalTrials.gov Identifier: NCT01941030     History of Changes
Other Study ID Numbers: CLARITY I
Study First Received: March 11, 2013
Last Updated: June 26, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014