NCT00232869

Brief Summary

The main objective of this study is to assess the safety and performance of the sirolimus coated Cordis SMART™ nitinol self expandable stent device and its delivery system in the treatment of obstructive superficial femoral artery (SFA) disease in reducing percent in-stent mean lumen diameter stenosis in de novo or restenotic native lesions as compared to the uncoated SMART™ stent.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
93

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

February 1, 2001

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2003

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

October 4, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 5, 2005

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2010

Enrollment Period

2.3 years

First QC Date

October 4, 2005

Last Update Submit

February 3, 2010

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

  • In-stent mean lumen diameter percent stenosis via quantitative angiography.

    6 months.

Study Arms (2)

1

EXPERIMENTAL

Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent

Device: drug-eluting stent

2

ACTIVE COMPARATOR

SMART™ bare-metal stent

Device: bare-metal stent

Interventions

drug-eluting stentDEVICE

Sirolimus Coated Cordis SMART™ nitinol selfexpandable stent

1
bare-metal stentDEVICE

SMART™ bare-metal stent

2

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One superficial femoral artery presenting \> 70% stenosis(es) or total occlusion
  • Symptomatic leg ischemia by Rutherford Classification (category 1, 2, 3 or 4)

You may not qualify if:

  • Tissue loss due to ischemic disease (Rutherford category 5 or 6).
  • Tandem lesion requiring non overlapping stents;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Tübingen, 72070, Germany

Location

Related Publications (1)

  • Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, Tielbeek A, Anderson J, Wiesinger B, Tepe G, Lansky A, Jaff MR, Mudde C, Tielemans H, Beregi JP. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006 Dec;13(6):701-10. doi: 10.1583/05-1704.1.

    PMID: 17154704RESULT

MeSH Terms

Conditions

Peripheral Arterial Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Intervention Hierarchy (Ancestors)

StentsProstheses and ImplantsEquipment and Supplies

Study Officials

  • Stephan H Duda, MD

    Tübingen - Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 4, 2005

First Posted

October 5, 2005

Study Start

February 1, 2001

Primary Completion

June 1, 2003

Study Completion

May 1, 2009

Last Updated

February 4, 2010

Record last verified: 2010-02

Locations

DE(1)