BIOFLOW III Satellite-ELADIS Orsiro Stent System
Launched by C.E.M. BIOTRONIK, S.A. · Jan 6, 2014
Trial Information
Current as of May 02, 2025
Completed
Keywords
ClinConnect Summary
For the majority of Coronary Artery Disease (CAD) treatment with Percutaneous Transluminal Coronary Angioplasty (PTCA) provides high initial procedure success. However, the medium to long-term complications range from rather immediate elastic coil or vessel contraction to longer processes like smooth muscle cell proliferation and excessive production of extra cellular matrix, thrombus formation and atherosclerotic changes like restenosis or angiographic re-narrowing. The reported incidence of restenosis after PTCA ranges from 30 to 50%. Such rates of recurrence have serious economic consequ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Symptomatic coronary artery disease
- • Subject has signed informed consent for data release
- • Subject is geographically stable and willing to participate at all follow up assessments
- • Subject is≥18 years of age.
- Exclusion Criteria:
- • Subject did not sign informed consent for data release
- • Pregnancy
- • Known intolerance to aspirin, clopidogrel, ticlopidine, heparin or any other anticoagulation, antiplatelet therapy required for PCI, stainless steel, Sirolimus or contrast media.
- • Planned surgery within 6 months after PCI unless dual antiplatelet therapy will be maintained
- • Currently participating in another study and primary endpoint is not yet reached.
About C.E.M. Biotronik, S.A.
c.e.m. biotronik, s.a. is a leading clinical trial sponsor specializing in innovative medical technologies and solutions for cardiovascular and vascular health. With a commitment to advancing patient care through rigorous research and development, the organization focuses on the design and execution of clinical trials that evaluate the safety and efficacy of its cutting-edge products. Leveraging a multidisciplinary team of experts, c.e.m. biotronik, s.a. aims to deliver transformative healthcare solutions while adhering to the highest ethical and regulatory standards in clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Sabadell, , Spain
Terrassa, , Spain
Badajoz, , Spain
Mérida, , Spain
Sevilla, , Spain
Barcelona, , Spain
Valencia, , Spain
León, A/Altos De Nava S/N, Spain
Cadiz, , Spain
Gasteiz / Vitoria, , Spain
Murcia, , Spain
Santiago De Compostela, , Spain
Valencia, , Spain
Vizcaya, , Spain
Patients applied
Trial Officials
Sonia Martin
Study Director
CEM BIOTRONIK SA
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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