The Valentines Trial

Instent Restenosis Clinical Trial

Official title:

The Valentines Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01066832
• Other study ID #: Eur-001
• Status: Completed
• Phase: Phase 4
• First received: February 9, 2010
• Last updated: June 16, 2011
• Start date: February 2010
• Est. completion date: March 2011

Study information

• Verified date: February 2010
• Source: Eurocor GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 276
• Est. completion date: March 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Instent Restenosis

Intervention

Drug:
• Paclitaxel
Paclitaxel-coated balloon (3 µg/mm2)

Locations

Country	Name	City	State
Germany	Heart Center Munich at the Isar	Munich
Italy	Policlinico	Modena
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Eurocor GmbH

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis		6-9 month	Yes
Secondary	In-stent and in-segment late loss and binary restenosis		6-9 month	No

External Links

•   Homepage of the trial