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NCT03717675
Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter
NA trial testing NovaCross™ Chronic Total Occlusion micro-catheter in Coronary Occlusion in 40 participants. Completed in 1 November 2019.
17 July 2019
Quick facts
| Lead sponsor | Nitiloop Ltd. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 October 2018 |
| Primary completion | 17 July 2019 |
| Estimated completion | 1 November 2019 |
| Sites | 3 locations across United Kingdom, Israel, Poland |
Drugs / interventions tested
- NovaCross™ Chronic Total Occlusion micro-catheter
Conditions studied
- Coronary Occlusion — all drugs for Coronary Occlusion →
Sponsor
Nitiloop Ltd.
Who can join
Adults 25 to 80, any sex, with Coronary Occlusion. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study will include up to 60 eligible male and female subjects. The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt. This study is an extension study of Nitiloop's Pivotal study.
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 NCT03717675
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Coronary Occlusion
Currently open trials in the same condition.
- NCT06878729 — Antegrade Dissection and Re-entry Versus Retrograde Strategy in CTO PCI · NA · recruiting
- NCT06528821 — AI-Powered ECG Detecting Culprit Vessel Blood Flow Abnormality in ACS · active not recruiting
- NCT06542393 — PBM as Strategy to CABG Anemic Patients Bypass Graft (CABG) · Phase 2 · recruiting
- NCT06681584 — Comparison of the Diagnostic Performance and Costs of FFRB Vs. Standard Care in Suspected Coronary Artery Disease. · active not recruiting
- NCT04604197 — ANGiographic Evaluation of Left Main Coronary Artery INtErvention · NA · active not recruiting
Other Nitiloop Ltd. trials
Trials by the same sponsor.
- NCT04862559 — A Single Center Study to Evaluate the Safety of the NovaCross Microcatheter in Crossing Chronic Total Occlusions · NA · completed
- NCT02477579 — A Prospective, Multi-Center, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in · 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 NCT03717675 (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 Nitiloop Ltd.
- Last refreshed: 3 December 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/NCT03717675.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing