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OpenTrials
Completed

NCT Number: NCT01066832

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.

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Key information

Conditions

Instent Restenosis

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Heart Center Munich at the Isar, Munich, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

paclitaxel

Drug

Paclitaxel-coated balloon (3 µg/mm2)

Primary outcomes

  1. Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis

    Time frame: 6-9 month

Secondary outcomes

  1. In-stent and in-segment late loss and binary restenosis

    Time frame: 6-9 month

Sponsors and collaborators

Lead sponsor

Eurocor GmbH

Industry

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Feb 10, 2010
Registry last updated
Jun 17, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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