SELUTION SLR 014 for Small Coronary Vessel Treatment

SELUTION 4 De Novo Small Vessel IDE Trial

Recruiting N/A Interventional Study
Coronary Artery Disease
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
960 (estimated)
Sponsor
M.A. Med Alliance S.A. · Industry
Who this trial is looking for

This trial is looking for adults with coronary artery disease who need treatment for small blood vessel problems in the heart. Participants will receive a specific medical device as part of their treatment and will be followed up to ensure safety and effectiveness.

Are You a Good Fit for This Trial?
Rules you out Chronic renal insufficiency

You may be able to join if

  • I am at least 18 years old
  • I have coronary artery disease with symptoms like chest pain
  • I can tolerate dual antiplatelet therapy
  • My doctor thinks I will live more than 1 year
  • I can give consent and follow study procedures
  • I have a specific type of lesion in my heart
  • I have had certain heart issues stabilized

You may not be able to join if

  • I am allergic to Sirolimus or similar drugs
  • I have had a heart attack within the last 30 days
  • I have ongoing chest pain or unstable health
  • I have had major surgery planned within 30 days
  • I am pregnant or planning to become pregnant within a year
  • I have severely low heart function
  • I am currently enrolled in another trial
  • I have active COVID-19

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
Prospective, randomized controlled, single-blind, multicenter, clinical trial to demonstrate the safety and efficacy of the SELUTION SLR 014 PTCA DEB for treatment of de novo lesions in small coronary vessels, defined as reference vessel diameter (RVD) of 2.00 mm to 2.75 mm, in support of a pre-market approval (PMA) application to the United States (US) FDA. The Study will enroll up to 910 random…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: * Clinical Inclusion Criteria Subjects must meet all of the following clinical criteria to participate in the trial: 1. Subject is ≥ 18 years (or the minimum legal age as required by local regulations). 2. Female subjects of childbearing potential must have a negative pregnanc…
Contacts

Rebecca Apruzzese

2016001527

rebecca.apruzzese@cordis.com

CONTACT

Susanne Meis

+491718918919

susanne.meis@cordis.com

CONTACT