The Valentines Trial

Study Overview
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Brief Summary
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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.

Official Title
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The Valentines Trial

Conditions
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Instent Restenosis

Intervention / Treatment
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* Drug: Paclitaxel


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Paclitaxel|Paclitaxel-coated balloon (3 µg/mm2)|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drug-eluting balloon, Paclitaxel, DIOR, short term registry, Valentines Trial, Drug-eluting balloon treatment of in-stent restenosis