Safety Study of a Bioresorbable Coronary Stent

NCT01262703 | Completed DMC

• 1 other identifier: HCT1000
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myocardial Ischemia; Coronary Artery Stenosis; Coronary Disease; Coronary Artery Disease; Coronary Restenosis; Cardiovascular Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• QCA & IVUS derived parameters

  12 months

• Major Adverse Coronary Events

  60 months

• Procedural and Technical Success

  Acute

Study Arms (1)

REVA Medical ReZolve Stent

EXPERIMENTAL

ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

Device: ReZolve Stent

Interventions

ReZolve Stent DEVICE

ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent

REVA Medical ReZolve Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• REVA Medical, Inc.: lead

Study Sites (1)

Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Alexandre Abizaid, MD

  Instituto Dante Pazzanese de Cardiologia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2010
• First Posted: December 17, 2010
• Study Start: December 1, 2011
• Primary Completion: October 1, 2013
• Study Completion: December 1, 2018
• Last Updated: March 29, 2023

Record last verified: 2023-03

Locations

BR (1)