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Search / Trial NCT03667313

Treatment of In-Stent Restenosis 2 Study

Launched by UNIVERSITY HOSPITAL OSTRAVA · Sep 11, 2018

Trial Information

Current as of June 04, 2025

Completed

Keywords

In Stent Restenosis; Sirolimus ; Paclitaxel Eluting Balloon

ClinConnect Summary

Current therapy for in-stent restenosis (ISR) is based on the drug-eluting stents (DES) or drug-eluting balloon catheters (DEB). In clinical practice, paclitaxel is used as an effective antiproliferative agent loaded into DEB (paclitaxel-eluting balloon catheters; PEB).

In contrast to paclitaxel, sirolimus is difficult to deliver on the balloon surface, due to insufficient tissue uptake and shorter tissue retention of limus drugs. It was found that phospholipid-encapsulated sirolimus nanoparticles could be used for coating balloon catheters to provide efficient drug transfer to vessel wall...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • patients with BMS- or DES-ISR (˃50% diameter stenosis; DS)
  • ≥18 years of age
  • willing to sign an Informed consent
  • Exclusion Criteria:
  • concomitant diseases with an expected survival time of less than 12 months
  • or that limited the possibility of control coronary aniography (e.g., advanced renal failure).
  • impossibility of long-term (6 months) dual antiplatelet treatment

About University Hospital Ostrava

University Hospital Ostrava is a leading medical research institution located in Ostrava, Czech Republic, dedicated to advancing healthcare through innovative clinical trials and research initiatives. As a prominent sponsor of clinical studies, the hospital combines cutting-edge medical technology with a commitment to patient-centered care, fostering collaborations among multidisciplinary teams of healthcare professionals and researchers. With a focus on ethical standards and regulatory compliance, University Hospital Ostrava aims to contribute to the development of new therapies and improve treatment outcomes across various medical fields. Its robust research infrastructure and dedication to scientific excellence position it as a key player in the advancement of medical knowledge and patient care.

Locations

Ostrava, , Czechia

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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