SeQuent Please Neo Multicenter Registry

SeQuent Please Neo Multicenter Registry / Registro Multicéntrico Sequent Please NEO

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04493112

Enrollment

1000

Registered

2020-07-30

Start date

2018-10-05

Completion date

2021-12-31

Last updated

2020-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug Coating Balloon (DCB), Sequent Please

Keywords

Drug coating Balloon (DCB), Sequent Please

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Success of balloon dilation.	Baseline	Success of balloon dilation.
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

Countries

Spain

Contacts

Primary ContactOriol Rodriguez, MD, PhD

Oriol.Rodriguez@gmail.com+34 93 497 89 89

Outcome results