NCT04285372

Keep bIfurcation Single Stenting Simple

A Randomized, Prospective, Post-market, Multicenter Study to Evaluate the Potential Benefit of Side Branch Ballooning, in the Setting of Single Stenting With Systematic Proximal Optimization Technique, in the Treatment of Bifurcation Lesion

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 596 (actual)
• Sponsor: Ceric Sàrl · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

KISS study is an investigator-initiated, multi-centre, prospective, randomized (1:1), parallel, two-arm, non-inferiority trial aiming to compare two bifurcation PCI procedures for Side Branch protection

Detailed description

In the treatment of bifurcation lesion, the role of side branch intervention for improving the safety of Percutaneous Coronary Intervention (PCI), when MB is treated according to the Murray law with a Proximal Optimization Technique (POT), remains unclear. The KISS study will evaluate the non-inferiority of no side branch intervention versus side branch ballooning, in the setting of single stenting with systematic proximal optimization technique.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
PROCEDURE	Side branch protection/ballooning	Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
PROCEDURE	No side branch protection/ballooning	No intervention on the side branch

Timeline

• Start date: 2020-08-03
• Primary completion: 2022-12-11
• Completion: 2024-04-01
• First posted: 2020-02-26
• Last updated: 2024-01-12

Locations

20 sites across 6 countries: France, Italy, Portugal, Spain, Switzerland, United Kingdom