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NCT05881421: PAD III OS
DISRUPT PAD III Observational Study
trial in Peripheral Arterial Disease in 1,373 participants. Completed in 10 June 2021.
10 June 2021
Quick facts
| Lead sponsor | Shockwave Medical, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 1,373 |
| Start date | 16 November 2017 |
| Primary completion | 10 June 2021 |
| Estimated completion | 10 June 2021 |
| Sites | 30 locations across New Zealand, United States, Germany |
Conditions studied
- Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →
Sponsor
Shockwave Medical, Inc. — full company profile →
Who can join
18 and older, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The Disrupt PAD III study was designed as a randomized controlled trial (RCT) with an additional observational registry component. The registry, referred to as the Disrupt PAD III Observational Study (PAD III OS), was a global, prospective, multi-center, single-arm registry of the Shockwave Peripheral Intravascular Lithotripsy (IVL) System. The objective of this study was to assess the real-world acute performance of IVL in the treatment of calcified, stenotic, peripheral arteries that may not qualify for inclusion in the RCT. The study was designed to enroll a maximum of 1500 subjects from up to 60 global sites with a minimum of 200 subjects treated with the S4 IVL catheter, a line extension designed to treat smaller diameter peripheral vessels, including calcified below-the-knee (BTK) lesions. Subjects were required to have target lesions in the iliac, femoral, ilio-femoral, popliteal, or infra-popliteal arteries with at least moderate calcification as determined by the investigator, defined as calcification within the lesion on both sides of the vessel assessed by angiography. Adjunctive therapies such as atherectomy, specialty balloons, and stents were allowed. Subjects were followed through discharge.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05881421
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Peripheral Arterial Disease
Currently open trials in the same condition.
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- NCT07336381 — Replexa+ Shortwave Diathermy Device for Patients Diagnosed With Peripheral Artery Disease and Peripheral Neuropathy · NA · recruiting
- NCT07076082 — Vascular Trial Associated Registry Pilot · Phase 4 · recruiting
- NCT06308562 — Fuzzy Wale Compression Stockinet to Promote Healing Following Transtibial Amputation for Peripheral Arterial Disease · NA · recruiting
Other Shockwave Medical, Inc. trials
Trials by the same sponsor.
- NCT06938854 — Investigational Study of SWM-831 to Treat Moderate and Severely Calcified Femoropopliteal Arteries · NA · active not recruiting
- NCT05966662 — Shockwave C2+ 2Hz Coronary IVL Catheter in Calcified Coronary Arteries (Disrupt CAD DUO) · NA · completed
- NCT05858905 — FORWARD PAD IDE Study With the Shockwave Javelin IVL Catheter · NA · completed
- NCT05058456 — Mini S Feasibility Study With Shockwave Medical Mini S Peripheral IVL System · NA · completed
- NCT05007925 — Disrupt PAD BTK II Study With the Shockwave Peripheral IVL System · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05881421 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Shockwave Medical, Inc.
- Last refreshed: 31 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05881421.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing