Safety Study of a Bioresorbable Coronary Stent (RESTORE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01262703
Recruitment Status : Active, not recruiting
First Posted : December 17, 2010
Last Update Posted : April 27, 2017
Information provided by (Responsible Party):
REVA Medical, Inc.

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

Condition or disease Intervention/treatment Phase
Myocardial Ischemia Coronary Artery Stenosis Coronary Disease Coronary Artery Disease Coronary Restenosis Cardiovascular Disease Device: ReZolve Stent Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent
Actual Study Start Date : December 2011
Actual Primary Completion Date : October 2013
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus
U.S. FDA Resources

Arm Intervention/treatment
Experimental: REVA Medical ReZolve Stent
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
Device: ReZolve Stent
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Primary Outcome Measures :
  1. Ischemia-driven Target Lesion Revascularization (TLR) [ Time Frame: 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 Outcome Measures :
  1. QCA & IVUS derived parameters [ Time Frame: 12 months ]
    Late Loss, Restenosis Rate, %DS, MLD & Neointimal Volume

  2. Major Adverse Coronary Events [ Time Frame: 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).

  3. Procedural and Technical Success [ Time Frame: Acute ]
    percentage of patients with angiographic success successful delivery and deployment of the device

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01262703

Instituto Dante Pazzanese de Cardiologia
Sao Paulo, Brazil
Sponsors and Collaborators
REVA Medical, Inc.
Principal Investigator: Alexandre Abizaid, MD Instituto Dante Pazzanese de Cardiologia

Responsible Party: REVA Medical, Inc. Identifier: NCT01262703     History of Changes
Other Study ID Numbers: HCT1000
First Posted: December 17, 2010    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Cardiovascular Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Coronary Stenosis
Coronary Restenosis
Heart Diseases
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs