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NCT03260517: PREVAIL
The PREVAIL Study
NA trial testing Medtronic Coronary Drug-Coated Balloon Catheter in In-stent Restenosis in 50 participants. Completed in 1 August 2019.
29 January 2019
Quick facts
| Lead sponsor | Medtronic Vascular |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 2 October 2017 |
| Primary completion | 29 January 2019 |
| Estimated completion | 1 August 2019 |
| Sites | 10 locations across Belgium, Italy, Netherlands |
Drugs / interventions tested
- Medtronic Coronary Drug-Coated Balloon Catheter
Conditions studied
- In-stent Restenosis — all drugs for In-stent Restenosis →
- Ischemic Heart Disease — all drugs for Ischemic Heart Disease →
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Medtronic Vascular — full company profile →
Who can join
Adults 18 to 85, any sex, with In-stent Restenosis or Ischemic Heart Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
To evaluate the clinical safety and efficacy of a new Medtronic Coronary Drug-Coated Balloon Catheter in the treatment of de novo lesions, small vessel disease or In-Stent Restenosis with coronary lesions previously treated with drug-eluting or bare metal stents in native coronary arteries.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Cost-effectiveness of strategies preventing late-onset infection in preterm infants.
Grosso A, Neves de Faria RI, Bojke L, Donohue C, et al · · 2020 · cited 4× · PMID 31836635 · DOI 10.1136/archdischild-2019-317640
Verify or expand the search:
- PubMed search for NCT03260517
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for In-stent Restenosis
Currently open trials in the same condition.
- NCT07297641 — Intravascular Imaging-Guided Versus Angiography- Guided PCI in Patients With DES-ISR · recruiting
- NCT06090890 — Anti-inflammatory Therapy for Recurrent In-stent Restenosis · Phase 4 · recruiting
- NCT06104007 — Safety and Efficacy of Paclitaxel Coated PTCA Balloon Catheter With a Shellac Plus Vitamin E Excipient (GENOSS® DCB) in · recruiting
- NCT05656118 — Safety and Efficacy of Paclitax Coated Balloon in Patients With Coronary In-stent Restenosis (ISR) · active not recruiting
Other Medtronic Vascular trials
Trials by the same sponsor.
- NCT07081243 — Symplicity China Study · recruiting
- NCT07115953 — Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension · NA · recruiting
- NCT07013929 — Spyral InSight Study · NA · recruiting
- NCT06907147 — SPYRAL GEMINI Pilot Study · NA · recruiting
- NCT05198674 — SPYRAL AFFIRM Global Study of RDN With the Symplicity Spyral RDN System in Subjects With Uncontrolled HTN · 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 NCT03260517 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Medtronic Vascular
- Last refreshed: 30 September 2019
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/NCT03260517.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing