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The Valentines Trial

NCT01066832 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 276

Last updated 2011-06-17

No results posted yet for this study

Summary

The primary objective of this multi-center, international, short term registry is to assess clinical success and efficacy of the paclitaxel eluting balloon treatment for in-stent restenosis at 6-9 months follow up. Clinical success defined as freedom from major adverse cardiac events (MACE: death, myocardial infarction \[MI\], target lesion revascularization \[TLR\]) and target vessel revascularization \[TVR\]) and stent thrombosis, both early and late occurrences will be assessed.

In addition, a cohort of the registry will undergo angiographic follow up at 6-9 months to assess in-stent and in-segment late loss and binary restenosis subsequent to paclitaxel eluting balloon treatment for in-stent restenosis.

A prioi analysis will be comparison of the safety and efficacy of patients presenting with drug-eluting stent in-stent restenosis to bare metal stent in-stent restenosis.

Conditions

  • Instent Restenosis

Interventions

DRUG

Paclitaxel

Paclitaxel-coated balloon (3 µg/mm2)

Sponsors & Collaborators

  • Eurocor GmbH

    lead INDUSTRY

Principal Investigators

  • Pieter Stella, MD, PhD · UMC Utrecht, Utrecht, Netherlands

  • Sigmund Silber, Prof. · Heart Center Munich at the Isar, Munich, Germany

  • Giuseppe Sangiorgi, MD · Policlinico Modena, Modena, Italy

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-02-28
Primary Completion
2010-12-31
Completion
2011-03-31

Countries

  • Germany
  • Italy
  • Netherlands

Study Locations

More Related Trials

Entities

Drugs

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 NCT01066832 on ClinicalTrials.gov