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The Valentines Trial

This study has been completed.
Sponsor:
Information provided by:
Eurocor GmbH
ClinicalTrials.gov Identifier:
NCT01066832
First received: February 9, 2010
Last updated: June 16, 2011
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Instent Restenosis
Drug: Paclitaxel
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Valentines Trial

Resource links provided by NLM:


Further study details as provided by Eurocor GmbH:

Primary Outcome Measures:
  • Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis [ Time Frame: 6-9 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • In-stent and in-segment late loss and binary restenosis [ Time Frame: 6-9 month ] [ Designated as safety issue: No ]

Enrollment: 276
Study Start Date: February 2010
Study Completion Date: March 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Paclitaxel
    Paclitaxel-coated balloon (3 µg/mm2)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01066832

Locations
Germany
Heart Center Munich at the Isar
Munich, Germany
Italy
Policlinico
Modena, Italy
Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
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
  More Information

Additional Information:
No publications provided

Responsible Party: Dr. Rembert Pogge von Strandmann, Eurocor GmbH
ClinicalTrials.gov Identifier: NCT01066832     History of Changes
Other Study ID Numbers: Eur-001
Study First Received: February 9, 2010
Last Updated: June 16, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Eurocor GmbH:
Drug-eluting balloon
Paclitaxel
DIOR
short term registry
Valentines Trial
Drug-eluting balloon treatment of in-stent restenosis

Additional relevant MeSH terms:
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 27, 2014