Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study

Study Overview
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Brief Summary
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The purpose of this study is to prospectively evaluate acute and long term clinical results of orbital atherectomy (OA) with adjunctive drug coated balloon (DCB) angioplasty versus DCB angioplasty alone for treatment of Peripheral Artery Disease (PAD) in below the knee (BTK) lesions.

Official Title
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Orbital Vessel PreparaTIon to MaximIZe Dcb Efficacy in Calcified Below the Knee (BTK) Lesions - A Pilot Study

Conditions
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PAD, Vascular Calcification

Intervention / Treatment
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* Device: Peripheral Orbital Atherectomy System
* Device: 014 Drug Coated Balloon


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject's age ≥ 18 years Rutherford Clinical Category 3 - 5 Lesions [except in-stent restenosis (ISR)] of the distal popliteal (POP segment below the anatomical knee joint), anterior tibial, posterior tibial, tibial peroneal trunk, and peroneal arteries with ≥ 70 % diameter stenosis (DS) by angiography Presence of clearly visible calcification in two views (both sides of vessel at the same location) evaluated angiographically- [Computerized tomography (CT) angio images may substitute to confirm distribution of calcium, if available as standard of care] Length of calcium ≥ 25 % of total lesion length or ≥ 2 cm total length Target lesion length up to 20 cm Exclusion Criteria: Subject or subject's legal representative is not willing to sign an Ethics Committee approved informed consent form or comply with the study protocol requirements Contraindicated by either device, per Instructions For Use Presence of inflow lesion (≥ 50 % DS) or inflow not successfully treated (≥ 50% DS and/or unresolved significant angiographic complication) Compromised outflow distal to the target lesion (≥ 70 % DS) or presence of lesion(s) or occlusion(s) located from 5 cm above the ankle to below the ankle joint space Subject has more than 2 target vessels requiring treatment The guide wire cannot be passed across the target lesion(s) and/or guide wire position distal to target lesion(s) outside vessel lumen Presence of significant (≥ 70 % DS) lesion(s) or occlusion(s) not meeting the study criteria which were not successfully treated during the index procedure (≥ 50 % DS and/or significant angiographic complication) Subject has planned amputation (including minor) of the index limb or previous major amputation of the contralateral limb Creatinine > 2.5 mg/dL, unless on dialysis Subject has any significant medical condition which, in the Investigator's opinion, may interfere with the subject's optimal participation in the study Subject is participating in an investigational drug or device study that has the potential to clinically interfere with the study outcome measures Subject is pregnant or planning to become pregnant within the study period Subject has an unresolved severe systemic infection Subject has an anticipated life span of less than one year Subjects with known hypersensitivity to paclitaxel or paclitaxel related compounds Subjects who cannot receive recommended anti-platelet and/or anticoagulant therapy Pre-dilatation of the target lesion prior to randomization and OA treatment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OA with adjunctive DCB angioplasty<br>Lesion preparation with Peripheral Orbital Atherectomy System followed by drug-coated balloon angioplasty | Device: Peripheral Orbital Atherectomy System<br>* Orbital Atherectomy<br>Device: 014 Drug Coated Balloon<br>* Drug Coated Balloon<br>|
| Active Comparator: DCB angioplasty<br>014 Drug Coated Balloon angioplasty | Device: 014 Drug Coated Balloon<br>* Drug Coated Balloon<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Success | Device success was defined as the ability to achieve successful delivery and deployment of the drug-coated balloon (DCB) to the target lesion as described per Instructions for Use (IFU) within 3 minutes of insertion without removal and use of an additional device. The percentage of success was based on the number of DCB devices used. | During the procedure | 
| Patency of the Target Lesion at 6 Months and 12 Months Post-Procedure | Patency of the target lesion as reported by the Duplex Ultrasound (DUS) Core Laboratory. Vessel patency at 6 months and 12 months by Duplex Ultrasound (DUS), where patency is defined as <50% restenosis within the treated lesion area. Patency was assessed by the DUS Core Laboratory. | 6 months and 12 months post-procedure | 
| Freedom From Clinically-Driven Target Lesion Revascularization (CD-TLR) at 6 Months and 12 Months Post-Procedure | A Kaplan-Meier analysis was performed to determine the percent probability that a study participant was free from CD-TLR through 6 months and 12 months. | 6 months and 12 months post-procedure | 
| Freedom From Unplanned, Unavoidable Major Amputation of the Index Limb at 6 Months and 12 Months Post-Procedure | A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from an unplanned, unavoidable major amputation of the index limb through 6 months and 12 months. | 6 months and 12 months post-procedure | 
| Freedom From Major Adverse Events (MAEs) at 6 Months and 12 Months Post-Procedure | A Kaplan-Meier analysis was performed to determine the percent probability that the study participant was free from a major adverse event (MAE) through 6 months and 12 months. Major adverse events were defined as: clinically-driven target lesion revascularization (CD-TLR); unplanned, unavoidable major amputation of the index limb; and death within 30 days of the index procedure. | 6 months and 12 months post-procedure | 
| Change in Rutherford Category at 6 Months and 12 Months Post-Procedure | Rutherford Classification (RC) is a commonly used clinical grading system for describing peripheral arterial disease (PAD) on a scale of 0 to 6. RC 6 is the most severe form of PAD. There are seven Rutherford categories used to grade the severity of peripheral artery disease; 0: asymptomatic, 1: mild claudication, 2: moderate claudication, 3: severe claudication, 4: ischemic rest pain, 5: minor tissue loss, 6: major tissue loss. The change in Rutherford category is presented as the distribution at baseline compared to that at 6- and 12-months post-procedure. | Baseline, 6 months and 12 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-coated Balloons, Calcified Lesions, Orbital Atherectomy, Below the Knee, Paclitaxel, Lutonix 014 Drug-coated Balloon