NCT02230254

PE PREMIER CHINA CLINICAL TRIAL

Completed NA Results posted Last updated 12 May 2022

What this trial tests

NA trial testing Percutaneous coronary intervention PROMUS PREMIER in Atherosclerosis in 101 participants. Completed in 31 July 2015.

Timeline

9 April 2014

Primary endpoint
22 June 2014

31 July 2015

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	101
Start date	9 April 2014
Primary completion	22 June 2014
Estimated completion	31 July 2015

Drugs / interventions tested

• Percutaneous coronary intervention PROMUS PREMIER

Conditions studied

• Atherosclerosis — all drugs for Atherosclerosis →

Sponsor

Boston Scientific Corporation — full company profile →

Who can join

Adults 18 to 75, any sex, with Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Technical Success Rate Primary · Participants will be followed for the duration of hospital stay, an expected average of 1 day

Technical success rate, defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of \<30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician

Group	Value	95% CI
PROMUS POREMIER Stent	99.1

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

PROMUS POREMIER Stent

Serious: 8/101 (8%)

Deaths: 0/101

Serious adverse events (8 terms)

Reaction	System	PROMUS POREMIER Stent
Angina pectoris	Cardiac disorders	—
Angina unstable	Cardiac disorders	—
Atrial fibrillation	Cardiac disorders	—
Intracardiac thrombus	Cardiac disorders	—
Ventricular extrasystoles	Cardiac disorders	—
Non-cardiac chest pain	General disorders	—
Diabetes mellitus	Metabolism and nutrition disorders	—
Subarachnoid haemorrhage	Nervous system disorders	—

Other adverse events (5 terms — click to expand)

Reaction	System	PROMUS POREMIER Stent
Angina pectoris	Cardiac disorders	—
Angina unstable	Cardiac disorders	—
Coronary artery dissection	Cardiac disorders	—
Gingival bleeding	Gastrointestinal disorders	—
Blood creatine phosphokinase increased	Investigations	—

Most-reported serious reactions: Angina pectoris, Angina unstable, Atrial fibrillation, Intracardiac thrombus, Ventricular extrasystoles, Non-cardiac chest pain, Diabetes mellitus, Subarachnoid haemorrhage.

Data from ClinicalTrials.gov NCT02230254 adverse events section.

Sponsor's own description

PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of Atherosclerotic Lesion(s)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.