Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)

Medtronic Endovascular133 enrolled

Overview

This is a multi-center, non-randomized, single arm study of the SilverHawk™ /TurboHawk™ plaque excision systems when used in conjunction with SpiderFX™ embolic protection device in treatment of moderate to severely calcified peripheral arterial disease in the superficial femoral and/or popliteal arteries.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

133

Conditions

Peripheral Arterial Disease

Interventions

SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection deviceDEVICE

Catheter-based excision of moderate to severely calcified plaque located in the SFA and/or popliteal artery.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Provides written informed consent * Willing to comply with follow-up evaluations at specified times * Has leg pain due to peripheral arterial disease * Disease located within the femoropopliteal artery * Moderate to severe calcification Exclusion Criteria: * Previously implanted stent(s) or stent graft(s) in target leg * Life expectancy less than 12 months * Has any planned surgical or endovascular intervention of target vessel 30 days before or after index procedure

Outcomes

Primary Outcomes

Successful Revascularization

Less than or equal to 50% residual diameter stenosis following plaque excision remaining at the target lesion(s), as adjudicated by the angiographic core laboratory

Time frame: at the end of the procedure

Major Adverse Event Free Rate 30 Days

MAE was defined as a serious adverse event that results in death, acute myocardial infarction, dissection (grade C or greater), clinical perforation, pseudo-aneurysm, thrombosis, distal embolism (clinically relevant), amputation, or clinically-driven target vessel revascularization (TVR), through 30 days post-procedure, as adjudicated by the Clinical Events Committee (CEC).

Time frame: 30 Days

Secondary Outcomes

Technical Procedural Success

Technical Procedural Success was defined as meeting all of the following requirements: * Less than or equal to 50% residual diameter stenosis at the target lesion(s), as adjudicated by the angiographic core laboratory * No procedure-related Major Adverse Events (MAE), as adjudicated by the Clinical Events Committee (CEC) * No device malfunction causing the procedure to be aborted * Successful delivery and placement of the SpiderFX™ embolic protection device

Time frame: at the end of the procedure

Residual Diameter Stenosis

This endpoint was met when there was less than 30% residual diameter stenosis following treatment with SilverHawk™ /TurboHawk™ plaque excision systems and any adjunctive therapy (if required), as adjudicated by the angiographic core laboratory.

Time frame: at the end of the procedure

Presence of Debris in Deployed SpiderFx™ Embolic Protection Device

Presence of debris in deployed SpiderFx™ embolic protection device

Time frame: at the end of the procedure

Data from ClinicalTrials.gov

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