Complete Lesion Assessment With ffR and IVUS TechnologY

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2015-06-30

Brief Summary

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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).

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Detailed Description

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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

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Peripheral Artery Disease Critical Limb Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Orbital Atherectomy System

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

Group Type EXPERIMENTAL

Orbital Atherectomy System

Intervention Type DEVICE

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

Balloon Angioplasty

Intervention Type DEVICE

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

Balloon Angioplasty

Balloon Angioplasty (BA) alone

Group Type ACTIVE_COMPARATOR

Balloon Angioplasty

Intervention Type DEVICE

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

Interventions

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Orbital Atherectomy System

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

Intervention Type DEVICE

Balloon Angioplasty

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

Intervention Type DEVICE

Eligibility Criteria

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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.

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.

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No