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Search / Trial NCT05788432

Sequent Extended Study

Launched by FUNDACIÓN EPIC · Mar 26, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Mdr (Medical Device Regulations) Pmcf (Post Market Clinical Follow Up) Paclitaxel Eluting Coronary Balloon Dilatation Catheter

ClinConnect Summary

The Sequent Extended Study is a research trial that aims to gather more information about the safety and effectiveness of a medical device called Sequent Please Neo, which is used to treat patients with coronary artery disease and ischemic heart disease. This study is important because it will help ensure that the device meets the required safety standards in Europe. The trial is currently recruiting participants who are between the ages of 65 and 74 and have been treated with this device in a hospital setting.

To be eligible for this study, patients must have received the Sequent Please Neo device according to the hospital's standard procedures and have signed an informed consent form, which means they understand what the study involves. However, individuals who are expected to live less than 12 months, have certain medical conditions that prevent them from taking necessary medications, or do not meet the inclusion criteria will not be able to participate. Those who join the study can expect to contribute valuable information that could help improve treatment for heart conditions in the future.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Patients treated with Sequent please neo according to routine hospital practice and following instruction for use.
  • Informed Consent Signed.
  • Exclusion Criteria:
  • Patient life expectancy less than 12 months.
  • Contraindication for antiplatelet therapy.
  • Not meet inclusion criteria.

About Fundación Epic

Fundación Epic is a leading clinical trial sponsor dedicated to advancing medical research and innovation. With a robust focus on improving patient outcomes, the foundation collaborates with healthcare professionals, research institutions, and industry partners to design and implement clinical studies across various therapeutic areas. Fundación Epic emphasizes ethical standards, scientific integrity, and patient safety, ensuring that all trials are conducted with the utmost care and rigor. Through its commitment to fostering cutting-edge research and promoting collaboration, Fundación Epic aims to contribute significantly to the development of new therapies and improve healthcare solutions globally.

Locations

Madrid, , Spain

Malaga, , Spain

Badalona, , Spain

Barcelona, , Spain

Madrid, , Spain

Sevilla, , Spain

Cadiz, , Spain

Elche, , Spain

Salamanca, , Spain

Barcelona, , Spain

Badajoz, , Spain

Málaga, , Spain

Huelva, , Spain

Ciudad Real, , Spain

Baracaldo, , Spain

Lugo, , Spain

Jaén, , Spain

Gijón, , Spain

Toledo, , Spain

Alicante, , Spain

Mérida, , Spain

Cáceres, , Spain

León, , Spain

Gerona, , Spain

Alava, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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