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Acrobat Coronary Stent System Effectiveness European Study

NCT01761591 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2014-08-26

No results posted yet for this study

Summary

The purpose of this randomized controlled trial (RCT) is to demonstrate the clinical benefit and impact on resource utilization of percutaneous coronary interventions (PCI) with the Svelte Acrobat Stent System compared to any other CE marked bare metal stent (BMS) implantable via direct stenting or after lesion pre-dilation, in patients with coronary lesions that are eligible for direct stenting and who are recruited and treated so as to reflect real-life routine practice.

Conditions

Interventions

DEVICE

PCI with Svelte Acrobat

Percutaneous coronary intervention with Svelte Acrobat Coronary Stent System

DEVICE

PCI with other BMS

Percutaneous coronary intervention with any other routine use CE marked bare metal stent (BMS) implantable either via direct stenting or after lesion pre-dilation

Sponsors & Collaborators

  • Svelte Medical Systems Europe

    lead INDUSTRY

Principal Investigators

  • Jean Fajadet, MD · Clinique Pasteur, 45 avenue Lombez, Toulouse 31300, France, Tel. 33 (0)5 62 21 16 99 - [email protected]

  • Andrew Schut · Svelte Medical Systems, Inc., 675 Central Avenue, New Providence, NJ 07974, USA, Tel. 1.908.264.2181 - [email protected]

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-01-31
Completion
2014-01-31

Countries

  • Belgium
  • France
  • Spain

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 NCT01761591 on ClinicalTrials.gov