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First in Man Study of the DREAMS 2nd Generation Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-II)

NCT01960504 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2020-01-18

No results posted yet for this study

Summary

BIOSOLVE-II is a prospective, international, multicenter, First in Man study. The purpose of this study is to assess the safety and clinical performance of the drug eluting absorbable metal scaffold (DREAMS 2nd Generation).

Conditions

Interventions

DEVICE

Percutaneous Coronary Intervention (DREAMS) stenting

Sponsors & Collaborators

  • Biotronik AG

    lead INDUSTRY

Principal Investigators

  • Michael Haude, MD · Städtische Kliniken Neuss

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-31
Primary Completion
2015-08-31
Completion
2020-05-31

Countries

  • Belgium
  • Brazil
  • Denmark
  • Germany
  • Netherlands
  • Singapore
  • Spain
  • Switzerland

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 NCT01960504 on ClinicalTrials.gov