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ABSORB PHYSIOLOGY Clinical Investigation

NCT01308346 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2013-05-07

No results posted yet for this study

Summary

The target enrollment goal for the trial was to enroll 36 subjects. However due to a challenging protocol inclusion/ exclusion criteria, only one subject was enrolled since the trial was initiated in June 2011.

To evaluate the following in participants undergoing coronary artery scaffolding/stenting for significant coronary artery disease:

* The acute (post-implantation) effect of an implanted bioresorbable vascular scaffold (BVS) or metallic drug eluting stent (mDES) on coronary blood flow and physiological responsiveness of the target coronary artery
* The long-term (2 years) effect of an implanted BVS or mDES on coronary blood flow and physiological responsiveness of the target coronary artery

Conditions

Interventions

DEVICE

Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)

Bioabsorbable Everolimus Eluting Coronary Stent

DEVICE

XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Ian Meredith, Prof, MD · Monash Medical Center

  • James Cameron, Prof, MD · Monash Medical Center

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Australia
  • China
  • Netherlands
  • Singapore

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01308346 on ClinicalTrials.gov