Safety Study of a Bioresorbable Coronary Stent

Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent

To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.

Today, coronary artery disease is often treated by placing a metal stent inside the vessel that serves as a permanent scaffold. However, it is hypothesized that the stent is no longer needed once the artery has healed. This study will evaluate the safety of a bioresorbable (non-permanent) stent for the treatment of coronary artery disease. The stent is designed to restore blood flow to the artery which allows the artery to remodel (heal), and then resorb from the body. The stent supports the vessel during the critical 90-day healing process, and then gradually resorbs and is cleared from the body.

Inclusion Criteria:

• Evidence of myocardial ischemia or a positive functional study.
• Normal CK-MB.
• Target lesion must be located in a native coronary artery where target vessel diameter is ≥ 2.9 mm and ≤ 3.3 mm and target lesion length is ≤ 12 mm, both assessed by on-line QCA and IVUS
• Target lesion must be in a major artery or branch with a visually estimated stenosis of ≥ 50% and < 100% with a TIMI flow of ≥ 2.
• Staged procedures are allowed in non-target vessels >24 hours before or > 30 days after REVA stent implantation

Exclusion Criteria:

• A myocardial infarction (CK-MB or Troponin > 3 times normal) within 72 hours of the procedure, has signs or symptoms of an ongoing myocardial infarction or has any visible thrombus
• Unprotected left main coronary disease with >50% stenosis
• The target vessel is totally occluded (TIMI Flow 0 to 1)
• Target lesion involves a bifurcation (a lesion with a side branch >2.0 mm in diameter containing a >50% stenosis)
• Target lesion is located within a segment supplied by distal graft
• Target lesion has possible or definite thrombus