The Valentines Trial

Phase 4

Completed

• Conditions: Instent Restenosis

• Registration Number: NCT01066832
• Lead Sponsor: Eurocor GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-02
• Study Start: 2010-02
• Study First Submitted: 2010-02-09
• Study First Submitted QC: 2010-02-09
• Study First Posted: 2010-02-10
• Primary Completion: 2010-12
• Study Completion: 2011-03
• Last Update Submitted: 2011-06-16
• Last Update Posted: 2011-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 276

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%.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis	6-9 month

Secondary Outcome Measures

Name	Time	Method
In-stent and in-segment late loss and binary restenosis	6-9 month

Trial Locations

Locations (3)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands

Policlinico; 🇮🇹 Modena, Italy

Heart Center Munich at the Isar; 🇩🇪 Munich, Germany