ReZolve2 Clinical Investigation (RESTORE II)

REVA Medical

Status: Completed

Conditions: Coronary Artery Disease; Coronary Artery Stenosis

Treatments: Device: ReZolve2 Scaffold

Study type: Interventional

Funder types: Industry

Identifiers

NCT01845311

HCT4000

Details and patient eligibility

About

The RESTORE II clinical trial is intended to assess safety and performance of the ReZolve2 Bioresorbable Coronary Scaffold in native coronary arteries.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Primary Inclusion Criteria:

• Patient has evidence of myocardial ischemia or a positive functional study
• Patient has a normal CK-MB
• Target lesion has a visually estimated stenosis of ≥50% and <100%
• Target lesion is located in a native coronary artery with average reference vessel diameter ≥ 2.75mm and ≤ 3.3mm
• Target lesion length must be ≤ 14mm

Primary Exclusion Criteria:

• Patient has experienced a myocardial infarction (CK-MB or Troponin > 5 X ULN) within 72 hours of the procedure
• Patient has a left ventricular ejection fraction < 30%
• Patient has unprotected lest main coronary disease with ≥50% stenosis
• The target vessel is totally occluded (TIMI Flow 0 or 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 bypass graft
• Target lesion has possible or definite thrombus

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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89 participants in 1 patient group

ReZolve2 Treatment Group

Experimental group

Treatment:

Device: ReZolve2 Scaffold