Last reviewed · How we verify
NCT03058627: NOTION-3
Revascularization in Patients Undergoing Transcatheter Aortic Valve Implantation
NA trial testing PCI in Coronary Artery Disease in 454 participants. Participants enrolled and being followed up; not accepting new ones.
15 January 2024
Quick facts
| Lead sponsor | Thomas Engstrom |
|---|---|
| Phase | NA |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 454 |
| Start date | 15 September 2017 |
| Primary completion | 15 January 2024 |
| Estimated completion | 15 November 2027 |
| Sites | 12 locations across Denmark, Finland, Sweden, Latvia |
Drugs / interventions tested
- PCI
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
- Aortic Valve Stenosis — all drugs for Aortic Valve Stenosis →
- TAVI — all drugs for TAVI →
- PCI — all drugs for PCI →
Sponsor
Thomas Engstrom — full company profile →
Who can join
18 and older, any sex, with Coronary Artery Disease or Aortic Valve Stenosis. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The aim of this study is to evaluate the effect of routine FFR-guided complete revascularization with PCI compared to conservative management in patients with concomitant coronary artery disease who are undergoing TAVI.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
PCI in Patients Undergoing Transcatheter Aortic-Valve Implantation.
Lønborg J, Jabbari R, Sabbah M, Veien KT, et al · · 2024 · cited 73× · PMID 39216095 · DOI 10.1056/nejmoa2401513 -
Long-Term Effects of Transcatheter Aortic Valve Implantation on Coronary Hemodynamics in Patients With Concomitant Coronary Artery Disease and Severe Aortic Stenosis.
Vendrik J, Ahmad Y, Eftekhari A, Howard JP, et al · · 2020 · cited 40× · PMID 32102615 · DOI 10.1161/jaha.119.015133 -
Comparison of Outcomes After Transcatheter Aortic Valve Replacement vs Surgical Aortic Valve Replacement Among Patients With Aortic Stenosis at Low Operative Risk.
Virtanen MPO, Eskola M, Jalava MP, Husso A, et al · · 2019 · cited 38× · PMID 31199448 · DOI 10.1001/jamanetworkopen.2019.5742 -
Percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation: a systematic review and meta-analysis.
Aarts HM, van Hemert ND, Meijs TA, van Nieuwkerk AC, et al · · 2023 · cited 21× · PMID 37910336 · DOI 10.1007/s12471-023-01824-w -
Coronary Microcirculation in Aortic Stenosis: Pathophysiology, Invasive Assessment, and Future Directions.
Zelis JM, Tonino PAL, Pijls NHJ, De Bruyne B, et al · · 2020 · cited 20× · PMID 32774184 · DOI 10.1155/2020/4603169 -
To revascularize or not before transcatheter aortic valve implantation?
Perez S, Thielhelm TP, Cohen MG. · · 2018 · cited 15× · PMID 30505538 · DOI 10.21037/jtd.2018.09.85 -
Combined CT Coronary Artery Assessment and TAVI Planning.
Renker M, Schoepf UJ, Kim WK. · · 2023 · cited 14× · PMID 37046545 · DOI 10.3390/diagnostics13071327 -
Non-hyperaemic pressure ratios to guide percutaneous coronary intervention.
Michail M, Thakur U, Mehta O, Ramzy JM, et al · · 2020 · cited 14× · PMID 33004619 · DOI 10.1136/openhrt-2020-001308
Verify or expand the search:
- PubMed search for NCT03058627
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of PCI
Trials testing the same drug.
- NCT07130188 — Predictors for ACS and Complexity of CAD · not yet recruiting
- NCT06542653 — Effect of PCI on Clinical Prognosis of Chronic Coronary Artery Occlusion · recruiting
- NCT06050096 — DCB Treatment in CTO Guided by IVUS · unknown
- NCT06214754 — Efficacy and Safety of Intravascular High-pressure Cutting Balloon Catheters for PCI · NA · completed
- NCT05292651 — Optimal Stent Deployment Strategy of Contemporary Stents · NA · recruiting
Other recruiting trials for Coronary Artery Disease
Currently open trials in the same condition.
- NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
- NCT07420582 — Antegrade Autologous Blood Reinfusion After CPB · recruiting
- NCT07493603 — A Study on Yiyang Huoluo Decoction in the Treatment of Coronary Heart Disease · Phase 1, PHASE2 · recruiting
- NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
- NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting
Other Thomas Engstrom trials
Trials by the same sponsor.
- NCT07478003 — Prehospital Pulse-dose Glucocorticoid in Patients With ST-segment Elevation Myocardial Infarction 2 - The PULSE-MI 2 Tri · Phase 3 · not yet recruiting
- NCT05462730 — Pulse Glucocorticoid Therapy in Patients With ST-Segment Elevation Myocardial Infarction · Phase 2 · completed
- NCT04775914 — STEMI Treatment Optimization by Ischemic Postconditioning and IVUS Guidance · NA · 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 NCT03058627 (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 Thomas Engstrom
- Last refreshed: 19 December 2023
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/NCT03058627.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing