- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04493112
SeQuent Please Neo Multicenter Registry
July 27, 2020 updated by: Germans Trias i Pujol Hospital
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.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
1000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Oriol Rodriguez, MD, PhD
- Phone Number: +34 93 497 89 89
- Email: Oriol.Rodriguez@gmail.com
Study Locations
-
-
Barcelona
-
Badalona, Barcelona, Spain
- Recruiting
- Hospital Universitari Germans Trias i Pujol
-
Contact:
- Oriol Rodriguez, MD, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
25 patients approx per site who fulfill inclusion/exclusion criteria.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
From baseline to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Success of balloon dilation.
Time Frame: Baseline
|
Success of balloon dilation.
|
Baseline
|
Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months.
Time Frame: From baseline to 12 months
|
MACE rate and MACE rate accumulated at 12 months.
|
From baseline to 12 months
|
Premature follow-up indication
Time Frame: From baseline to 12 months
|
Premature follow-up indication
|
From baseline to 12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Oriol Rodriguez, MD, PhD, Germans Trias I Pujol Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 5, 2018
Primary Completion (ANTICIPATED)
December 31, 2021
Study Completion (ANTICIPATED)
December 31, 2021
Study Registration Dates
First Submitted
July 27, 2020
First Submitted That Met QC Criteria
July 27, 2020
First Posted (ACTUAL)
July 30, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 30, 2020
Last Update Submitted That Met QC Criteria
July 27, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- Sequent Please NEO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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