SeQuent Please Neo Multicenter Registry | NCT04493112

Studies
SeQuent Please Neo Multicenter Registry

NCT04493112

Sponsor

Germans Trias i Pujol Hospital

Status

Unknown status

Last Update Posted

Jul 30, 2020Actual

Enrollment

1,000Estimated

Phase

Not provided

Conditions

Drug Coating Balloon (DCB), Sequent Please

Interventions

Not provided

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 5, 2018Actual

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Jul 27, 2020

First Submission Date that Met QC Criteria

Jul 27, 2020

First Posted Date

Jul 30, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 27, 2020

Last Update Posted Date

Jul 30, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

1,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.	Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.	From baseline to 12 months

Secondary Outcomes

Measure	Description	Time Frame
Success of balloon dilation.	Success of balloon dilation.	Baseline
Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months.	MACE rate and MACE rate accumulated at 12 months.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

25 patients approx per site who fulfill inclusion/exclusion criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Oriol Rodriguez, MD, PhD	Contact	+34 93 497 89 89		Oriol.Rodriguez@gmail.com

Overall Officials

Name	Affiliation	Role
Oriol Rodriguez, MD, PhD	Germans Trias i Pujol Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitari Germans Trias i Pujol	Recruiting	Badalona	Barcelona		Spain

Condition Browse Module

MeSH Terms

ID	Term
D003117	Color Vision Defects

Ancestor Terms

ID	Term
D014786	Vision Disorders
D012678	Sensation Disorders
D009461	Neurologic Manifestations
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided