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

Determination of Safety and Effectiveness of the SilverHawk™ Peripheral Plaque Excision System for Calcium (SilverHawk LS-C) and the SpiderFX™ Embolic Protection Device for the Treatment of Calcified Peripheral Arterial Disease in the Superficial Femoral and/or the Popliteal Arteries (DEFINITIVE Ca++)

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 Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease
• Intervention / Treatment: Device: SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device

• Study Type: Interventional
• Enrollment (Actual): 133
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: Atherectomy with embolic protection; All subjects were treated with atherectomy (with SilverHawk or TurboHawk device) in conjunction with embolic protection (SpiderFX device).	Device: SilverHawk™ LS-C, TurboHawk™ LS-C, TurboHawk™ LX-C plaque excision systems and SpiderFX™ embolic protection device; Catheter-based excision of moderate to severely calcified plaque located in the SFA and/or popliteal artery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	30 Days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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.	at the end of the procedure
Presence of Debris in Deployed SpiderFx™ Embolic Protection Device	Presence of debris in deployed SpiderFx™ embolic protection device	at the end of the procedure
Preservation of Run-off Distal to the Filter	Preservation of run-off distal to SpiderFX™ distal embolic protection device was determined by angiography of run-off vessels at the end of the procedure, as adjudicated by the angiographic core laboratory.	at the end of the procedure

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: David Roberts, MD, Sutter Medical Center

Publications and helpful links

General Publications

• Roberts D, Niazi K, Miller W, Krishnan P, Gammon R, Schreiber T, Shammas NW, Clair D; DEFINITIVE Ca(+)(+) Investigators. Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection: final results of the DEFINITIVE Ca(+)(+) trial. Catheter Cardiovasc Interv. 2014 Aug 1;84(2):236-44. doi: 10.1002/ccd.25384. Epub 2014 Feb 5.

Study record dates

Study Major Dates

• Study Start: October 1, 2008
• Primary Completion (ACTUAL): November 1, 2010
• Study Completion (ACTUAL): November 1, 2010

Study Registration Dates

• First Submitted: August 8, 2008
• First Submitted That Met QC Criteria: August 11, 2008
• First Posted (ESTIMATE): August 12, 2008

Study Record Updates

• Last Update Posted (ESTIMATE): August 26, 2015
• Last Update Submitted That Met QC Criteria: August 14, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: atherosclerosis; atherectomy; calcified lesions; peripheral vascular disease
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: FHT-P-07-003