Last reviewed · How we verify
NCT04674475: OPTI-XIENCE
OPTImized Coronary Interventions eXplaIn the bEst cliNical outcomEs
trial testing Pressure guidewire, optimal coherence tomography in Coronary Artery Disease in 1,000 participants. Status unknown.
31 May 2022
Quick facts
| Lead sponsor | Spanish Society of Cardiology |
|---|---|
| Status | Status unknown |
| Study type | OBSERVATIONAL |
| Enrollment | 1,000 |
| Start date | 3 May 2021 |
| Primary completion | 31 May 2022 |
| Estimated completion | 16 June 2023 |
Drugs / interventions tested
- Pressure guidewire, optimal coherence tomography
Conditions studied
- Coronary Artery Disease — all drugs for Coronary Artery Disease →
Sponsor
Spanish Society of Cardiology
Who can join
18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Hypothesis: the clinical outcome of patients with indication of PCI and coronary stent implantation that are at high risk of events can be improved with a widespread use of intra-coronary tools that allow a PCI optimization (i.e. functional assessment by pressure guidewire and intra-coronary imaging techniques). Objective: to evaluate whether the use of pressure guidewire and intra-coronary imaging techniques (mainly optimal coherence tomography) in patients at high risk of events undergoing coronary angiography for myocardial revascularization is associated with an improved clinical outcome in comparison with patient with angiographic alone guided cobalt-chromium everolimus-eluting coronary stenting. Methods: Prospective observational multicentric international study with a follow-up of 12 months, including 1.000 patients in 40 sites located in 3 European countries (Spain, France, and Portugal). The control group will be comprised by a similar number of matched patients included in the "extended-risk" cohort of the XIENCE V USA study. PCI will be performed following local standard protocols and accordingly to the physician criteria. The use of pressure guidewire will be recommended according to the current guidelines, in patients with angiographically intermediate lesions and in those with multivessel disease. The use of OCT will be strongly recommended, as patients included will be considered to be at high risk of events, accordingly to the current recommendations. The primary endpoint will be target lesion failure (TLF) at 1 year.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04674475
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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 Spanish Society of Cardiology trials
Trials by the same sponsor.
- NCT06755801 — Nebivolol ANOCA Treatment Randomized Trial · Phase 3 · not yet recruiting
- NCT05619601 — Gender Differences in Prevention Strategies and Therapeutic Adherence After Acute Myocardial Infarction · active not recruiting
- NCT05825339 — Absolute Flow for Ischemia With No Obstructive Coronary Arteries · unknown
- NCT04850417 — Randomized Study of Beta-Blockers and Antiplatelets in Patients With Spontaneous Coronary Artery Dissection · Phase 4 · not yet recruiting
- NCT04696185 — Dapagliflozin After Transcatheter Aortic Valve Implantation · Phase 4 · 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 NCT04674475 (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 Spanish Society of Cardiology
- Last refreshed: 19 December 2020
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/NCT04674475.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing