Trials / Completed
CompletedNCT03268018
ModificatiOn and Treatment of stenoseD Calcified inFrainguinal Lesions With Laser atherectomY in a Pilot Study
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- Spectranetics Corporation · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The MODIFY Pilot clinical study in Europe looks to evaluate acute and procedural outcomes using a new calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes. The MODIFY Pilot study will evaluate safety and performance measurements.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Laser induced pressure wave calcium modification | A calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes |
Timeline
- Start date
- 2017-06-07
- Primary completion
- 2017-10-31
- Completion
- 2018-03-18
- First posted
- 2017-08-31
- Last updated
- 2019-04-18
Locations
2 sites across 1 country: Belgium
Source: ClinicalTrials.gov record NCT03268018. Inclusion in this directory is not an endorsement.