CI

At a glance

ClinicalIndex Comparison Record
N/AActive· 180 enrolled / 180 target
Drug / intervention
Device: Paclitaxel-Coated PTCA Balloon Catheter +1 moredevice
Likely dose
2.0 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04058990
NCT04058990N/AActiveUpdate Overdue (2.3/mo)Completion was 54mo ago
CompareCT.gov

A 2:1 Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.

Boston Scientific Corporation·interventional·Posted Aug 16, 2019·Updated Jun 26, 2026

In Brief

A clinical study evaluating Device: Paclitaxel-Coated PTCA Balloon Catheter and SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel for Coronary Artery Disease. Active but no longer recruiting, targeting 180 participants across 14 sites.

Signals

Enrollment appears stalled

Detailed Summary

A Randomized Trial Comparing the Agent Paclitaxel-Coated PTCA Balloon Catheter vs SeQuent Please Drug Eluting Balloon Catheter for the Treatment of a Small Vessel De Novo Native Coronary Artery Lesion.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCoronary Artery Disease
CountriesJapan
Collaborators--

Timeline

N/AActiveOverdue
2020202120222023202420252026
First PostedAug 16, 2019
Enrollment StartDec 12, 2019
Primary CompletionDec 22, 2021
Study CompletionJun 30, 2026
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 6.9 years ago

Arms & Interventions

Agent Paclitaxel-Coated PTCA Balloon Catheterexperimental

Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (Agent Paclitaxel-Coated PTCA Balloon Catheter with paclitaxel 2.0 μg/mm²)

Device: Device: Paclitaxel-Coated PTCA Balloon Catheter
SeQuent Please Drug Eluting Balloon Catheteractive_comparator

Treatment of a Small Vessel De Novo Native Coronary Artery Lesion with a paclitaxel-coated balloon. (SeQuent Please Drug Eluting Balloon Catheter with paclitaxel 3.0 μg/mm²)

Device: SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel

Interventions

Device: Paclitaxel-Coated PTCA Balloon Catheterdevice

Percutaneous Transluminal Coronary Angioplasty

SeQuent Please Drug Eluting Balloon Catheter with Paclitaxeldevice

Percutaneous Transluminal Coronary Angioplasty