Last reviewed · How we verify
NCT04861519: AutocathFFR
Pivotal, Single-arm Clinical Trial to Assess the Efficacy and Safety of the MedHub AutocathFFR Software Device
trial testing Collecting invasive FFR measurements. in Stable Angina in 308 participants. Completed in 31 December 2021.
30 October 2021
Quick facts
| Lead sponsor | Medhub Ltd. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 308 |
| Start date | 9 May 2021 |
| Primary completion | 30 October 2021 |
| Estimated completion | 31 December 2021 |
| Sites | 3 locations across Israel |
Drugs / interventions tested
- Collecting invasive FFR measurements.
Conditions studied
- Stable Angina — all drugs for Stable Angina →
- Unstable Angina — all drugs for Unstable Angina →
- NSTEMI — all drugs for NSTEMI →
Sponsor
Medhub Ltd.
Who can join
18 and older, any sex, with Stable Angina or Unstable Angina. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Prospective (analysis of retrospective data), multi-center, observational, single-arm study. This structure was selected as the "worst case" due to the fact that it represents real life usage of invasive FFR measurement is performed mostly in "gray zone" cases, which are that their severity cannot be determined intuitively and based on the physician eyeball. By using real-world historical data of invasive FFR, the analysis of the obtained data can ensure that the study results are expected to include invasive FFR results that are in the grey zone, when invasive FFR is used in real life and represent the real expected use of the product. Furthermore, the analysis of the data obtained in the studies with these similar devices measuring FFR obtained from angiograms was actually performed in a retrospective manner. That is, although the angiographic images and pressure wire recordings were obtained in real-time, due to the need to mark the vessel in real-time and obtain specific projections during the procedure without which the FFR cannot be calculated, the primary endpoint (sensitivity and specificity) and accuracy were determined in all studies by a post-hoc review by a similar independent QCA core laboratory. The invasive FFR data, as well as the software generated FFR data were reviewed post-hoc by a core laboratory or even at the company.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Performance of a novel artificial intelligence software developed to derive coronary fractional flow reserve values from diagnostic angiograms.
Ben-Assa E, Abu Salman A, Cafri C, Roguin A, et al · · 2023 · cited 11× · PMID 37855304 · DOI 10.1097/mca.0000000000001305
Verify or expand the search:
- PubMed search for NCT04861519
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Collecting invasive FFR measurements.
Trials testing the same drug.
- NCT06183294 — Evaluation of a Novel Non-Invasive Automated Fractional Flow Reserve Software System in Patients With Coronary Artery Di · completed
Other recruiting trials for Stable Angina
Currently open trials in the same condition.
- NCT06436092 — Japanese Coronary Intervention Using Drug Eluting and Perfusion Therapy for Left Main Disease (JDEPTH-LM Registry) · recruiting
- NCT05972070 — Integration of Telemedicine and Home-Based Cardiac Rehabilitation: Feasibility, Efficacy, and Adherence · recruiting
- NCT05865600 — Perfusion Estimation For Optimal Treatment Strategy in Chronic Coronary Syndrome · NA · recruiting
- NCT05230446 — PRospective Evaluation of Complete Revascularization in Patients With multiveSsel Disease Excluding chroNic Total Occlus · NA · recruiting
- NCT05255705 — Barts Revascularisation Registry · recruiting
Other Medhub Ltd. trials
Trials by the same sponsor.
- NCT04724057 — Post Marketing Clinical Trial to Demonstrate the Performance of the MedHub AutocathFFR Device. · NA · unknown
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 NCT04861519 (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 Medhub Ltd.
- Last refreshed: 26 March 2024
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/NCT04861519.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing