NCT00733135

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
133

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2008

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 8, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 12, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2008

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

July 4, 2014

Completed
Last Updated

August 26, 2015

Status Verified

August 1, 2015

Enrollment Period

2.1 years

First QC Date

August 8, 2008

Results QC Date

June 5, 2014

Last Update Submit

August 14, 2015

Conditions

Peripheral Arterial Disease

Keywords

peripheral vascular diseaseatherectomyatherosclerosiscalcified lesions

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Technical Procedural Success

    at the end of the procedure

  • Residual Diameter Stenosis

    at the end of the procedure

  • Presence of Debris in Deployed SpiderFx™ Embolic Protection Device

    at the end of the procedure

  • Preservation of Run-off Distal to the Filter

    at the end of the procedure

Study Arms (1)

Atherectomy with embolic protection

OTHER

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

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.

Atherectomy with embolic protection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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 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.

    PMID: 24402764RESULT

MeSH Terms

Conditions

Peripheral Arterial DiseasePeripheral Vascular DiseasesAtherosclerosis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Director of Medical Communications
Organization
Covidien
jean.ahlstrom@covidien.com
763-591-3047

Study Officials

  • Daniel Clair, MD

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

  • David Roberts, MD

    Sutter Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 8, 2008

First Posted

August 12, 2008

Study Start

October 1, 2008

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

August 26, 2015

Results First Posted

July 4, 2014

Record last verified: 2015-08