Cardiovascular Disease, Coronary Artery Disease, Coronary Artery Stenosis, Coronary Disease, Coronary Restenosis, Myocardial Ischemia
Conditions
Brief summary
To evaluate the safety of a new bioresorbable (non-permanent) stent platform in native coronary arteries.
Detailed description
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.
Interventions
DEVICEReZolve Stent
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
Sponsors
REVA Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ischemia-driven Target Lesion Revascularization (TLR) | 6 months | Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| QCA & IVUS derived parameters | 12 months | Late Loss, Restenosis Rate, %DS, MLD & Neointimal Volume |
| Major Adverse Coronary Events | 60 months | Major Adverse Cardiac Events - Combined events consisting of death, Myocardial Infarction (Q-Wave, Non Q-wave: CPK \> 2xULN + MB\>ULN) (MI), and target vessel revascularization (TVR). |
| Procedural and Technical Success | Acute | percentage of patients with angiographic success successful delivery and deployment of the device |
Countries
Brazil
Outcome results
None listed