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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
History of Changes
  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:

Drug Information available for: Paclitaxel
U.S. FDA Resources

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
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:
Homepage of the trial  This link exits the ClinicalTrials.gov site

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
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013