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

February 9, 2010
June 16, 2011
February 2010
December 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01066832 on ClinicalTrials.gov Archive Site
In-stent and in-segment late loss and binary restenosis [ Time Frame: 6-9 month ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Valentines Trial
The Valentines Trial

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.

Not Provided
Interventional
Phase 4
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Instent Restenosis
Drug: Paclitaxel
Paclitaxel-coated balloon (3 µg/mm2)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
276
March 2011
December 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany,   Italy,   Netherlands
 
NCT01066832
Eur-001
Not Provided
Dr. Rembert Pogge von Strandmann, Eurocor GmbH
Eurocor GmbH
Not Provided
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
Eurocor GmbH
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP