Safety Study of a Bioresorbable Coronary Stent (RESTORE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
REVA Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01262703
First received: December 16, 2010
Last updated: January 28, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention
Myocardial Ischemia
Coronary Artery Stenosis
Coronary Disease
Coronary Artery Disease
Coronary Restenosis
Cardiovascular Disease
Device: ReZolve Stent

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pilot Study of the ReZolve™ Sirolimus-Eluting Bioresorbable Coronary Stent

Resource links provided by NLM:


Further study details as provided by REVA Medical, Inc.:

Primary Outcome Measures:
  • Ischemia-driven Target Lesion Revascularization (TLR) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    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:
  • QCA & IVUS derived parameters [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Late Loss, Restenosis Rate, %DS, MLD & Neointimal Volume

  • Major Adverse Coronary Events [ Time Frame: 60 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Acute ] [ Designated as safety issue: Yes ]
    percentage of patients with angiographic success successful delivery and deployment of the device


Estimated Enrollment: 50
Study Start Date: December 2011
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: REVA Medical ReZolve Stent
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
Device: ReZolve Stent
ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01262703

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

No publications provided

Responsible Party: REVA Medical, Inc.
ClinicalTrials.gov Identifier: NCT01262703     History of Changes
Other Study ID Numbers: HCT1000
Study First Received: December 16, 2010
Last Updated: January 28, 2014
Health Authority: Brazil: National Health Surveillance Agency (Anvisa)
Germany: Federal Institute for Drugs and Medicinal Devices (BfArM)

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

ClinicalTrials.gov processed this record on July 29, 2014