Last reviewed · How we verify
NCT04339699: STITCH
NobleStitch EL STITCH Trial is a PFO Comparative Trial
NA trial testing NobleStitch™EL Suture Mediated Closure System in Foramen Ovale, Patent in 640 participants. Currently enrolling.
31 December 2026
Quick facts
| Lead sponsor | Nobles Medical Technologies II Inc |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 640 |
| Start date | 1 January 2021 |
| Primary completion | 31 December 2026 |
| Estimated completion | 30 June 2027 |
| Sites | 2 locations across Italy, United States |
Drugs / interventions tested
- NobleStitch™EL Suture Mediated Closure System
- Amplatzer PFO Occluder
Conditions studied
- Foramen Ovale, Patent — all drugs for Foramen Ovale, Patent →
- Stroke, Ischemic — all drugs for Stroke, Ischemic →
Sponsor
Nobles Medical Technologies II Inc — full company profile →
Who can join
Adults 18 to 60, any sex, with Foramen Ovale, Patent or Stroke, Ischemic. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
STITCH - Prospective Multi-Center Comparative Parallel Concurrent Study of the NobleStitch™ EL versus FDA-approved Amplatzer Occluder device for closure of Patent Foramen Ovale to prevent recurrent Ischemic stroke.
Publications & conference data
4 peer-reviewed publications reference this trial (live from Europe PMC):
-
Teleproctoring for Training in Structural Heart Interventions: Initial Real-World Experience During the COVID-19 Pandemic.
Beyhoff N, Zhu M, Zanders L, Leistner DM, et al · · 2022 · cited 8× · PMID 35132869 · DOI 10.1161/jaha.121.023757 -
Transcatheter Interventions in Patients With Adult Congenital Heart Disease.
Tan W, Stefanescu Schmidt AC, Horlick E, Aboulhosn J. · · 2022 · cited 6× · PMID 39132367 · DOI 10.1016/j.jscai.2022.100438 -
Transcatheter PFO closure for cryptogenic stroke: current approaches and future considerations.
Eltelbany M, Gattani R, Ofosu-Somuah A, Damluji A, et al · · 2024 · cited 5× · PMID 38832314 · DOI 10.3389/fcvm.2024.1391886 -
Noblestitch® system for PFO closure: A novel but judicious alternative to traditional devices-A case report.
Onorato EM, Grancini L, Monizzi G, Mastrangelo A, et al · · 2023 · cited 4× · PMID 37063961 · DOI 10.3389/fcvm.2023.1095661
Verify or expand the search:
- PubMed search for NCT04339699
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Foramen Ovale, Patent
Currently open trials in the same condition.
- NCT04881578 — Atrial Fibrillation Before and After Patent Foramen Ovale Closure Study · 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 NCT04339699 (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 Nobles Medical Technologies II Inc
- Last refreshed: 23 March 2026
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/NCT04339699.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing