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

Peripheral Arterial Disease Clinical Trial

Official title:

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++)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00733135
• Other study ID #: FHT-P-07-003
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: August 8, 2008
• Last updated: August 14, 2015
• Start date: October 2008
• Est. completion date: November 2010

Study information

• Verified date: August 2015
• Source: Medtronic Endovascular
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Medtronic Endovascular

References & Publications (1)

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 re — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	Yes
Secondary	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	Yes
Secondary	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	No
Secondary	Presence of Debris in Deployed SpiderFx™ Embolic Protection Device	Presence of debris in deployed SpiderFx™ embolic protection device	at the end of the procedure	No
Secondary	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	Yes