Trials / Completed
CompletedNCT01183117
A Clinical Investigation of SM-01 Stenting Versus PTA for the Treatment of Superficial Femoral Artery Disease
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 105 (actual)
- Sponsor
- Johnson & Johnson K.K. Medical Company · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The main objective is to evaluate the safety and efficacy of SM-01 stenting (Cordis S.M.A.R.T.™ Nitinol Stent System) for the treatment of SFA lesions as compared to PTA (balloon angioplasty). If SM-01 is used in a PTA-bailout patient, the case will be assessed separately.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | SM-01 | SM-01 is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery. |
| DEVICE | PTA | balloon angioplasty |
Timeline
- Start date
- 2010-07-01
- Primary completion
- 2012-09-01
- Completion
- 2014-08-01
- First posted
- 2010-08-17
- Last updated
- 2015-04-02
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01183117. Inclusion in this directory is not an endorsement.