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Scoreflex NC - Scoring PTCA Catheter

NCT03763747 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2021-08-11

Study results available
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Summary

A prospective, open label, multi-center, single arm, observational study designed to evaluate the acute safety and device procedural success of the Scoreflex NC Scoring Percutaneous Transluminal Coronary Angioplasty (PTCA) catheters in subjects with stenotic coronary arteries during percutaneous coronary intervention.

Two-hundred (200) subjects will be treated at up to 15 U.S. sites with the Scoreflex NC Scoring PTCA catheter during their index procedure. All subjects will be screened according to the protocol inclusion and exclusion criteria and will be followed through hospital discharge.

Conditions

Interventions

DEVICE

Scoreflex NC Scoring PTCA catheter

To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters

Sponsors & Collaborators

  • ClinLogix. LLC

    collaborator INDUSTRY

  • OrbusNeich

    lead INDUSTRY

Principal Investigators

  • David Kandzari, MD · Piedmont Heart Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-27
Primary Completion
2019-12-27
Completion
2019-12-27
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT03763747 on ClinicalTrials.gov