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NCT02554266: BTKRegistry
Registry Investigating the Clinical Use and Safety of the Lutonix Drug Coated Balloon for Treatment of BTK Arteries
trial testing Lutonix 014 Drug Coated Balloon PTA Catheter in Peripheral Artery Disease in 371 participants. Completed in 22 November 2019.
31 May 2018
Quick facts
| Lead sponsor | C. R. Bard |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 371 |
| Start date | 29 September 2015 |
| Primary completion | 31 May 2018 |
| Estimated completion | 22 November 2019 |
| Sites | 26 locations across France, Italy, Greece, Belgium, Austria, Saudi Arabia, United Kingdom, Germany |
Drugs / interventions tested
- Lutonix 014 Drug Coated Balloon PTA Catheter
Conditions studied
- Peripheral Artery Disease — all drugs for Peripheral Artery Disease →
Sponsor
C. R. Bard — full company profile →
Who can join
18 and older, any sex, with Peripheral Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study will enroll patients presenting with claudication, or critical limb ischemia (Rutherford Category 3- 5) and an angiographically significant (≥ 70%) native artery lesion appropriate for angioplasty that is below the knee. Subjects will be treated with the Lutonix Drug Coated Balloon (DCB) carrying the CE Mark per current IFU and followed clinically for a minimum of 2 years.
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 NCT02554266
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Peripheral Artery Disease
Currently open trials in the same condition.
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- NCT04433572 — Temsirolimus Adventitial Delivery to Improve ANGioplasty and/or Atherectomy Revascularization Outcomes Below the Knee · Phase 3 · recruiting
- NCT06890208 — Chronical Illness-related Limitations of the Ability to Cope With Rising Temperatures, Third Wave · recruiting
- NCT07012070 — Improving Walking Performance in Patients With Peripheral Artery Disease Through Wearable Activity Trackers · NA · recruiting
Other C. R. Bard trials
Trials by the same sponsor.
- NCT06934486 — Observational Study of TissuePatch SF in Prevention of Air Leaks Following Lung Resection · not yet recruiting
- NCT07016698 — Real-World Registry of the Rotarex(TM) Rotational Excisional Atherectomy System (XTRACT Registry) · NA · recruiting
- NCT06850259 — This Study Will Collect Clinical and Patient Reported Satisfaction Data From Males Requiring Urine Output Management Ove · NA · completed
- NCT06669806 — Effectiveness and Safety of TIPS Stent Graft in the Treatment of Cirrhosis and Complications of Portal Hypertension · NA · recruiting
- NCT06666426 — This Study Will Collect Clinical and Patient Reported Experience Data From Participants Requiring Urine Output Managemen · NA · completed
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 NCT02554266 (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 C. R. Bard
- Last refreshed: 13 January 2020
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/NCT02554266.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing