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NCT05858905 · ClinicalTrials.gov registry record · NA
FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter
A NA study, sponsored by Shockwave Medical.
- Completed
- Registry status
- NA
- Development phase
- 55
- Enrollment target
NCT05858905: Completed NA study, sponsored by Shockwave Medical.
NCT05858905 is a NA study that has completed, run by Shockwave Medical. The registered enrollment target is 55 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05858905, a NA study, has completed, sponsored by Shockwave Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 55 participants
- Enrollment target
Study Summary
The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
Primary Outcome
Major Adverse Events (MAE) at 30 days defined as a composite of: * Cardiovascular death * Clinically-Driven Target Lesion Revascularization (CD-TLR) * Unplanned Target Limb Major Amputation (Above the Ankle)
Interventions
- DEVICE Intravascular Lithotripsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2023-06-27 |
| Est. Completion | 2025-04-21 |
| Phase | NA |
What the finished NCT05858905 record still lists
NCT05858905 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 1 intervention - of which Intravascular Lithotripsy is the first listed.
NCT05858905 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05858905 about?
NCT05858905 is a clinical study titled "FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter". The FORWARD PAD IDE Study is a prospective, multi-center, single-arm investigational device exemption study, conducted to assess the safety and effectiveness of the Shockwave Medical Mini S Peripheral IVL System for the treatment of heavily calcified, stenotic peripheral arteries.
What is the current status of trial NCT05858905?
This trial is currently completed. It is a NA study. The enrollment target is 55 participants. The study started on 2023-06-27. Estimated completion is 2025-04-21.
What interventions are being tested in trial NCT05858905?
The interventions under investigation include: Intravascular Lithotripsy (DEVICE).
Who is sponsoring clinical trial NCT05858905?
This trial is sponsored by Shockwave Medical, which has 13 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05858905's enrollment target sits among peer trials
55 1264th of 2000 higher than 733 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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