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REal World Advanced Experience of BioResorbable ScaffolD by SMart Angioplasty Research Team (SMART REWARD)

NCT02601404 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2017-03-03

No results posted yet for this study

Summary

Current drug-eluting stents (DES) has demonstrated excellent clinical outcomes in patients with coronary artery disease. However, a continued risk of clinical events even several years after the procedure is reported. Stent platform or polymer-associated inflammation may play a role.

Bioresorbable scaffold (BRS) is known to disappear 2 to 3 years after the implantation, which may result in the more favorable very long-term clinical outcomes compared with metallic stents. The initial clinical experiences of BRS in relatively simple lesion subsets were comparable to DESs.

BRS, however, is limited by the disadvantageous mechanical characteristics such as thick strut and the risk of fracture by overdilation. There is concern that BRS is less optimal for complex lesion subsets such as bifurcation lesions, calcified tortuous lesions, or diffuse long lesions. Real world registry is needed to test the feasibility and safety of BRS in these complex lesion subsets.

Conditions

  • Acute Coronary Syndromes

Interventions

DEVICE

Bioresorbable scaffold (BRS)

The implantation procedure of an Absorb™ is similar to a metallic stent.

Sponsors & Collaborators

  • Samsung Medical Center

    lead OTHER

Eligibility

Min Age
19 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-30
Primary Completion
2022-12-31
Completion
2022-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02601404 on ClinicalTrials.gov