The Valentines Trial

June 16, 2011 updated by: Eurocor GmbH

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

276

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany
        • Heart Center Munich at the Isar
  • Italy
      • Modena, Italy
        • Policlinico
  • Netherlands
      • Utrecht, Netherlands
        • UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients, male or female, > 18 years of age;
  • Patients who present with in-stent restenosis of a previously placed stent documented by coronary angiogram for which re-PCI is planned;
  • The patient has stable or unstable angina, and/or clinical evidence of ischemia (ECG, exercise test, etc.);
  • The target lesion is in a native vessel;
  • Up to two lesions per patient;
  • Target lesion(s) stenosis is > 50%.

Exclusion Criteria:

  • The patient has had an acute myocardial infarction within the last 48 hours;
  • The patient has a co-morbid illness (i.e. any illness likely to limit his/her life expectancy to <12 months);
  • Lesion(s) requiring additional stenting either bare metal or drug eluting (non, bail-out indications);
  • The patient has had previous therapeutic radiation to the target vessel;
  • The patient is unable the take dual antiplatelet therapy for at least 6 months;
  • Patients with three or more lesions with in-stent restenosis requiring angioplasty.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis
Time Frame: 6-9 month
6-9 month

Secondary Outcome Measures

Outcome Measure
Time Frame
In-stent and in-segment late loss and binary restenosis
Time Frame: 6-9 month
6-9 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eurocor GmbH

Investigators

  • Principal Investigator: Pieter Stella, MD, PhD, UMC Utrecht, Utrecht, Netherlands
  • Principal Investigator: Sigmund Silber, Prof., Heart Center Munich at the Isar, Munich, Germany
  • Principal Investigator: Giuseppe Sangiorgi, MD, Policlinico Modena, Modena, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 9, 2010

First Submitted That Met QC Criteria

February 9, 2010

First Posted (Estimate)

February 10, 2010

Study Record Updates

Last Update Posted (Estimate)

June 17, 2011

Last Update Submitted That Met QC Criteria

June 16, 2011

Last Verified

February 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Eur-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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