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ABSORB Post-Approval Clinical Study

NCT02943616 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-01-11

No results posted yet for this study

Summary

The ABSORB Post-Approval Clinical Study is a prospective, open-label, multi-center, single-arm, non-randomized trial to evaluate the safety of the use of ABSORB in a real-world setting following commercial physician training'and to observe the effectiveness of commercial physician training on appropriate vessel sizing.

Conditions

  • Ischemic Heart Disease

Interventions

DEVICE

Absorb BVS

Commercially approved Absorb GT1 BVS, herein referred to as "Absorb". * Scaffold diameters: 2.5, 3.0, and 3.5 mm * Scaffold lengths: 8, 12, 18, 23 and 28 mm Absorb is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Peter Staehr · Abbott Medical Devices

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-31
Primary Completion
2018-12-31
Completion
2021-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT02943616 on ClinicalTrials.gov