Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
89 participants
INTERVENTIONAL
2013-04-30
2019-01-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety Study of a Bioresorbable Coronary Stent
NCT01262703
POST-APPROVAL STUDY of TRANSCAROTID ARTERY REVASCULARIZATION in PATIENTS With SIGNIFICANT CAROTID ARTERY DISEASE
NCT02536378
Safety and Feasibility of the Injectable BL-1040 Implant
NCT00557531
REPRISE II: REpositionable Percutaneous Replacement of Stenotic Aortic Valve Through Implantation of Lotus™ Valve System
NCT01627691
Randomized Trial Evaluating Slow-Release Formulation TAXUS Paclitaxel-Eluting Coronary Stent in the Treatment of In-Stent Restenosis
NCT00287573
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ReZolve2 Treatment Group
ReZolve2 Scaffold
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ReZolve2 Scaffold
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
REVA Medical, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Alexandre Abizaid, MD
Role: PRINCIPAL_INVESTIGATOR
Instituto Dante Pazzanese de Cardiologia
David Muller, MD
Role: PRINCIPAL_INVESTIGATOR
St Vincent's Hospital, Sydney
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
St Vincent's Hospital
Sydney, , Australia
Instituto Dante Pazzanese de Cariologia
São Paulo, , Brazil
Cardioangiologisches Centrum Bethanien
Frankfurt, , Germany
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HCT4000
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.