SeQuent Please Neo Multicenter Registry

Germans Trias i Pujol Hospital

Status: Unknown

Conditions: Drug Coating Balloon (DCB), Sequent Please

Study type: Observational

Funder types: Other

Identifiers

NCT04493112

Sequent Please NEO

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.