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Status unknownNCT04493112Updated Jul 30, 2020

SeQuent Please Neo Multicenter Registry

An observational study in Drug Coating Balloon (DCB), Sequent Please, sponsored by Germans Trias i Pujol Hospital. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-30.

Sponsored by Germans Trias i Pujol Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Drug Coating Balloon (DCB), Sequent Please

Keywords

  • Drug coating Balloon (DCB), Sequent Please
03

In context

Lead sponsor

Germans Trias i Pujol Hospital is the lead sponsor of 87 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

25 patients approx per site who fulfill inclusion/exclusion 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

Exclusion Criteria:

  • There is no exclusion criteria except those patients with contraindication for antiplatelet therapy.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.

    Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.

    Time frame: From baseline to 12 months

Secondary outcomes

  1. Success of balloon dilation.

    Success of balloon dilation.

    Time frame: Baseline

  2. Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months.

    MACE rate and MACE rate accumulated at 12 months.

    Time frame: From baseline to 12 months

  3. Premature follow-up indication

    Premature follow-up indication

    Time frame: From baseline to 12 months

07

Study locations

1 of 1 sites recruiting
  • Hospital Universitari Germans Trias i Pujol
    Badalona, Barcelona, Spain
    • Oriol Rodriguez, MD, PhD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04493112
Lead sponsor
Germans Trias i Pujol Hospital
Responsible party
Sponsor
First posted
Jul 30, 2020
Start date
Oct 5, 2018
Primary completion
Dec 31, 2021 (estimated)
Completion
Dec 31, 2021 (estimated)
Last update
Jul 30, 2020

Study contacts

Oriol Rodriguez, MD, PhD
Contact
Oriol.Rodriguez@gmail.com
+34 93 497 89 89
Oriol Rodriguez, MD, PhD
principal investigator · Germans Trias i Pujol Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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