Drug Coating Balloon (DCB), Sequent PleaseNCT04493112
SeQuent Please Neo Multicenter Registry
An observational study of Drug Coating Balloon (DCB), Sequent Please, run by Germans Trias i Pujol Hospital at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Drug Coating Balloon (DCB), Sequent Please
- How many people
- 1,000 participants
- Where
- 1 siteSpain
- Study dates
- 5 Oct 2018to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 25 patients approx per site who fulfill inclusion/exclusion criteria.
Who may be able to join
- 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
Who cannot join
- There is no exclusion criteria except those patients with contraindication for antiplatelet therapy.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona
Oriol Rodriguez, MD, PhD
About this study
Official title: SeQuent Please Neo Multicenter Registry / Registro Multicéntrico Sequent Please NEO
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.
- Keywords
- Drug coating Balloon (DCB), Sequent Please
- Medical subject headings
- Color Vision Defects
What is being measured
The primary outcome is the main question the study is designed to answer.
Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.
Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.
Measured: From baseline to 12 months
Secondary outcomes (3)
Success of balloon dilation.
Success of balloon dilation.
Measured: Baseline
Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months.
MACE rate and MACE rate accumulated at 12 months.
Measured: From baseline to 12 months
Premature follow-up indication
Premature follow-up indication
Measured: From baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2020
- Study start5 Oct 2018
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug Coating Balloon (DCB), Sequent PleaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oriol Rodriguez, MD, PhD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04493112
- Sponsor's protocol ID
- Sequent Please NEO
- Status last verified
- Jul 2020
- First submitted
- 27 Jul 2020
- Last updated
- 30 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SeQuent Please Neo Multicenter Registry / Registro Multicéntrico Sequent Please NEO
- ClinicalTrials.gov ID
- NCT04493112
- Acronym / sponsor ID
- Sequent Please NEO
- Keywords
- Drug coating Balloon (DCB), Sequent Please
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 5 Oct 2018 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 30 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 25 patients approx per site who fulfill inclusion/exclusion criteria.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- There is no exclusion criteria except those patients with contraindication for antiplatelet therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.
Time frame: From baseline to 12 months
Target Lesion Revascularization (TLR) with clinical follow-up at 12 months.
3 secondary outcomes
Success of balloon dilation.
Time frame: Baseline
Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months.
Time frame: From baseline to 12 months
Premature follow-up indication
Time frame: From baseline to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oriol Rodriguez, MD, PhD principal investigator
Germans Trias i Pujol Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Drug Coating Balloon (DCB), Sequent Please, run by Germans Trias i Pujol Hospital at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oriol Rodriguez, MD, PhD (+34 93 497 89 89, Oriol.Rodriguez@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Target Lesion Revascularization (TLR) with clinical follow-up at 12 months. (time frame: From baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2020.