Clinical trial NCT01066832: The Valentines Trial
Official title: The Valentines Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Instent Restenosis
Keywords: Drug-eluting balloon
Paclitaxel
DIOR
short term registry
Valentines Trial
Drug-eluting balloon treatment of in-stent restenosis
Lead sponsor: Eurocor GmbH
Sponsor class: INDUSTRY
First posted: 2010-02-10
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis
timeFrame: 6-9 month
Secondary outcomes:
measure: In-stent and in-segment late loss and binary restenosis
timeFrame: 6-9 month
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Heart Center Munich at the Isar
city: Modena
country: Italy
facility: Policlinico
city: Utrecht
country: Netherlands
facility: UMC Utrecht
Study officials:
affiliation: UMC Utrecht, Utrecht, Netherlands
name: Pieter Stella, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Heart Center Munich at the Isar, Munich, Germany
name: Sigmund Silber, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Policlinico Modena, Modena, Italy
name: Giuseppe Sangiorgi, MD
role: PRINCIPAL_INVESTIGATOR
References: