SeQuent Please Neo Multicenter Registry

• Conditions: Drug Coating Balloon (DCB), Sequent Please

• Registration Number: NCT04493112
• Lead Sponsor: Germans Trias i Pujol Hospital

Brief Summary

The registry evaluates the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The objective is to determine the success of the procedure and the preservation of vascular permeability.

Detailed Description

The preset registry aim is to evaluate the safety and efficacy of paclitaxel-releasing SeQuent® Please Neo balloon in the following scenarios: restenosis, bifurcation lesions, small vessel lesions, diabetes (diffuse disease) and atrial fibrillation. The principal objective is to determine the success of the procedure and the preservation of vascular permeability.

Study Timeline

• Study Start: 2018-10-05
• Status Verified: 2020-07
• Study First Submitted: 2020-07-27
• Study First Submitted QC: 2020-07-27
• Last Update Submitted: 2020-07-27
• Study First Posted: 2020-07-30
• Last Update Posted: 2020-07-30
• Primary Completion: 2021-12-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• ISR in a coronary artery with a diameter stenosis of at least 70%, a length of the stented segment of <25 mm, and a vascular diameter of at least 2.5 and up to 3.5 mm

Exclusion Criteria

• There is no exclusion criteria except those patients with contraindication for antiplatelet therapy.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.	From baseline to 12 months	Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.

Secondary Outcome Measures

Name	Time	Method
Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months.	From baseline to 12 months	MACE rate and MACE rate accumulated at 12 months.
Premature follow-up indication	From baseline to 12 months	Premature follow-up indication
Success of balloon dilation.	Baseline	Success of balloon dilation.

Trial Locations

Locations (1)

Hospital Universitari Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain