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NCT02464501 · ClinicalTrials.gov registry record · NA
The OPC for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis - Above and Below the Knee
A NA study of Cardiovascular Disease and Peripheral Arterial Disease, sponsored by Horizons International Peripheral Group.
- Completed
- Registry status
- NA
- Development phase
- 112
- Enrollment target
- 17
- Study locations
NCT02464501: Completed NA study of Cardiovascular Disease and Peripheral Arterial Disease, sponsored by Horizons International Peripheral Group.
NCT02464501 is a NA study of Cardiovascular Disease and Peripheral Arterial Disease that has completed, run by Horizons International Peripheral Group. The registered enrollment target is 112 participants, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (96% lower). The trial reports 17 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02464501, a NA study of Cardiovascular Disease and Peripheral Arterial Disease, has completed, sponsored by Horizons International Peripheral Group.
- COMPLETED
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
- 17
- Study locations
Study Summary
The purpose of this study is to assess the safety and efficacy of paclitaxel administration using the occlusion perfusion catheter (OPC) for the prevention of restenosis in infrainguinal de novo, restenotic femoropopliteal and infrapopliteal stenoses and occlusions, and in-stent restenosis.
Primary Outcome
Femoropopliteal Lesions: Measured by duplex Doppler ultrasound (DUS) - demonstrated by Peak Systolic Velocity Ratio (PSVR) ≤ 2.5 and clinically free from Target Lesion Revascularization.
Conditions Studied
Interventions
- OTHER Paclitaxel administration using the OPC
Study Locations (17)
Texas
- Huntsville Memorial Hospital - Huntsville
- North Dallas Research Associates - McKinney
- Cardiovascular Associates of East Texas - Tyler
- Tyler Cardiovascular Consultants - Tyler
Michigan
- Michigan Outpatient Vascular Institute - Dearborn
- St. John Hospital - Detroit
- Mid-Michigan Heart & Vascular Center - Saginaw
Florida
- First Coast Cardiovascular Institute - Jacksonville
- Coastal Vascular and Interventional - Pensacola
Tennessee
- University Surgical Associates - Chattanooga
- Kore Cardiovascular Research - Jackson
Alabama
- Cardiology Associates - Fairhope
Iowa
- Vascular Institute of the Midwest - Davenport
Louisiana
- Cardiovascular Institute of the South - Houma
Mississippi
- Hattiesburg Clinic - Hattiesburg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2015-05-20 |
| Est. Completion | 2019-11 |
| Phase | NA |
What the finished NCT02464501 record still lists
NCT02464501 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 2,697-participant average among 137 other Cardiovascular Disease trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Cardiovascular Disease appearing as the primary indexed condition, and to 1 intervention - of which Paclitaxel administration using the OPC is the first listed.
NCT02464501 lists 17 locations in 10 states (Texas, Michigan, Florida).
Frequently Asked Questions
What is clinical trial NCT02464501 about?
NCT02464501 is a clinical study titled "The OPC for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis - Above and Below the Knee". The purpose of this study is to assess the safety and efficacy of paclitaxel administration using the occlusion perfusion catheter (OPC) for the prevention of restenosis in infrainguinal de novo, restenotic femoropopliteal and infrapopliteal stenoses and occlusions, and in-stent restenosis.
What is the current status of trial NCT02464501?
This trial is currently completed. It is a NA study. The enrollment target is 112 participants. The study started on 2015-05-20. Estimated completion is 2019-11.
What conditions does trial NCT02464501 study?
This clinical trial studies the following conditions: Cardiovascular Disease, Peripheral Arterial Disease, Peripheral Vascular Disease.
What interventions are being tested in trial NCT02464501?
The interventions under investigation include: Paclitaxel administration using the OPC (OTHER).
Who is sponsoring clinical trial NCT02464501?
This trial is sponsored by Horizons International Peripheral Group, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02464501 being conducted?
This trial has 17 study locations across Alabama, Florida, Iowa, Louisiana, Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02464501's enrollment target sits among peer trials
112 72nd of 137 higher than 65 of 137 other Cardiovascular Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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