ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Clinical Trial Summary

The primary objectives of this trial are:

In patients at high-risk for restenosis,

- To assess non-inferiority of the everolimus-eluting bioresorbable scaffold (BRS) to the everolimus eluting cobalt chromium metallic stent (EES) in target lesion failure (TLF) at 1 year

- To assess superiority of the BRS to the EES in TLF between 3 and 7 years

NCT number	NCT02486068
Study type	Interventional
Source	European Cardiovascular Research Center
Contact
Status	Active, not recruiting
Phase	N/A
Start date	September 28, 2015
Completion date	September 2024

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ABSORB Bioresorbable Scaffold vs. Xience Metallic Stent for Prevention of Restenosis in Patients at High Risk of Restenosis — Compare Absorb

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms