The Valentines Trial

NCT ID: NCT01066832

Last Updated: 2011-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 276 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2011-03-31

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.

Conditions

Instent Restenosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Paclitaxel

Paclitaxel-coated balloon (3 µg/mm2)

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurocor GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Eurocor GmbH

Principal Investigators

Pieter Stella, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht, Utrecht, Netherlands

Sigmund Silber, Prof.

Role: PRINCIPAL_INVESTIGATOR

Heart Center Munich at the Isar, Munich, Germany

Giuseppe Sangiorgi, MD

Role: PRINCIPAL_INVESTIGATOR

Policlinico Modena, Modena, Italy

Locations

Heart Center Munich at the Isar

Munich, , Germany

Policlinico

Modena, , Italy

UMC Utrecht

Utrecht, , Netherlands

Countries

Germany; Italy; Netherlands

Other Identifiers

Eur-001

Identifier Type: -

Identifier Source: org_study_id