NCT02491255 is a NA clinical trial of Lotus Valve System in Aortic Stenosis, sponsored by Boston Scientific Corporation.

Who is sponsoring NCT02491255?

NCT02491255 is sponsored by Boston Scientific Corporation.

What drugs are being tested in NCT02491255?

Interventions in NCT02491255: Lotus Valve System.

What condition does NCT02491255 study?

NCT02491255 studies Aortic Stenosis.

Is NCT02491255 still recruiting?

NCT02491255 is currently completed. Last updated 28 September 2021.

Last reviewed 2021-09-28 · How we verify

NCT02491255

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement (REPRISE Japan)

Completed NA Last updated 28 September 2021

What this trial tests

NA trial testing Lotus Valve System in Aortic Stenosis in 70 participants. Completed in 13 September 2021.

Timeline

22 June 2015

Primary endpoint
30 January 2017

13 September 2021

Quick facts

Lead sponsor	Boston Scientific Corporation
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	70
Start date	22 June 2015
Primary completion	30 January 2017
Estimated completion	13 September 2021
Sites	5 locations across Japan

Drugs / interventions tested

Lotus Valve System

Conditions studied

Aortic Stenosis — all drugs for Aortic Stenosis →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

20 and older, any sex, with Aortic Stenosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of this study is to confirm the safety and effectiveness of the Lotus™ Valve System in the Japanese medical environment for transcatheter aortic valve replacement (TAVR) in symptomatic subjects with calcific, severe native aortic stenosis who are considered at high or extreme risk for surgical valve replacement.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Transcatheter aortic valve implantation in Asia.
Hon JKF, Tay E. · · 2017 · cited 10× · PMID 29062746 · DOI 10.21037/acs.2017.08.05

Verify or expand the search:

Other trials of Lotus Valve System

Trials testing the same drug.

NCT02202434 — Safety and Efficacy Study of Lotus Valve for Transcatheter Aortic Valve Replacement · NA · terminated
NCT02031302 — RESPOND Post Market Study · completed
NCT01627691 — REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System · NA · completed

Other recruiting trials for Aortic Stenosis

Currently open trials in the same condition.

NCT07197736 — DELINEATE-Prospective · recruiting
NCT07230964 — Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacemen · NA · recruiting
NCT07205068 — Improved Outcomes With Pre-Procedure Shockwave IVL of Common Femoral Artery Access Site Prior to Large Bore Access and P · NA · recruiting
NCT07052071 — Impact of Transcatheter Aortic Valve Implantation (TAVI) on the Gut Microbiota in Patients With Aortic Valve Stenosis · recruiting
NCT07144189 — AI Assessment of Low-Gradient Aortic Stenosis Severity Based on Echocardiography · recruiting

Other Boston Scientific Corporation trials

Trials by the same sponsor.

NCT07458243 — Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT · not yet recruiting
NCT07458217 — Combined CM and STN Stimulation for Motor Epilepsy · NA · not yet recruiting
NCT07276815 — OverStitch NXT Endoscopic Suture System · NA · not yet recruiting
NCT07353710 — A Study on the Acquisition of 2D ICE Images With the CHORUS IDx System in Subjects Undergoing an Ablation Procedure · NA · not yet recruiting
NCT07195708 — Orbera365 Intragastric Balloon System (Abbreviated as'Orbera365') · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02491255 (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 Boston Scientific Corporation
Last refreshed: 28 September 2021

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/NCT02491255.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing