NCT03947398

Brief Summary

The purpose of this study is to investigate the effectivness of the Blimp Scoring balloon compared to current available CTO balloon catheters.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 28, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 28, 2019

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2021

Completed
Last Updated

January 27, 2023

Status Verified

March 1, 2019

Enrollment Period

2 years

First QC Date

March 28, 2019

Last Update Submit

January 26, 2023

Conditions

Percutaneous Coronary InterventionChronic Total Occlusion of Coronary Artery

Outcome Measures

Primary Outcomes (1)

  • Successful crossing through lesion and dilatation with BLIMP or low profile balloon

    passing of BLIMP or low profile balloon through lesion. If device passess it will be determined a successful outcome, if it does not pass, an unsuccesful outcome.

    The primary outcome is a procedural assessment

Study Arms (2)

Treatment with BLIMP first

EXPERIMENTAL
Device: BLIMP balloon

Treatment with low-profile balloon first

ACTIVE COMPARATOR
Device: Low profile balloon

Interventions

BLIMP balloonDEVICE

Using BLIMP balloon to cross lesion

Treatment with BLIMP first
Low profile balloonDEVICE

using low profile balloon to cross lesion

Treatment with low-profile balloon first

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Severe coronary lesion where microcatheter or dilatation balloon does not cross

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johan Bennett

Leuven, Brabant, 3001, Belgium

Location

ZOL Genk

Genk, 3600, Belgium

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 28, 2019

First Posted

May 13, 2019

Study Start

March 28, 2019

Primary Completion

March 28, 2021

Study Completion

March 28, 2021

Last Updated

January 27, 2023

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations

BE(2)