Safety Study of a Bioresorbable Coronary Stent

Coronary Artery Disease Clinical Trial

— RESTORE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01262703
• Other study ID #: HCT1000
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: December 2018

Study information

• Verified date: March 2023
• Source: REVA Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: December 2018
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Coronary Artery Disease
• Coronary Artery Stenosis
• Coronary Disease
• Coronary Restenosis
• Coronary Stenosis
• Ischemia
• Myocardial Ischemia

Intervention

Device:
• ReZolve Stent
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Locations

Country	Name	City	State
Brazil	Instituto Dante Pazzanese de Cardiologia	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
REVA Medical, Inc.

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ischemia-driven Target Lesion Revascularization (TLR)	Defined as any clinically-driven (as defined for TLR) repeat percutaneous intervention of the target vessel or bypass surgery of the target vessel.	6 months
Secondary	QCA & IVUS derived parameters	Late Loss, Restenosis Rate, %DS, MLD & Neointimal Volume	12 months
Secondary	Major Adverse Coronary Events	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).	60 months
Secondary	Procedural and Technical Success	percentage of patients with angiographic success successful delivery and deployment of the device	Acute