Drug Coating Balloon (DCB), Sequent Please Clinical Trial
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.
| Status | Recruiting |
| Enrollment | 1000 |
| Est. completion date | December 31, 2021 |
| Est. primary completion date | December 31, 2021 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona |
| Lead Sponsor | Collaborator |
|---|---|
| Germans Trias i Pujol Hospital |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Success of balloon dilation. | Success of balloon dilation. | Baseline | |
| Secondary | Acute adverse cardiac events rate (MACE) and and MACE rate accumulated at 12 months. | MACE rate and MACE rate accumulated at 12 months. | From baseline to 12 months | |
| Secondary | Premature follow-up indication | Premature follow-up indication | From baseline to 12 months |