The Valentines Trial
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Eurocor GmbH
- Enrollment
- 276
- Locations
- 3
- Primary Endpoint
- Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis
Time Frame: 6-9 month
Secondary Outcomes
- In-stent and in-segment late loss and binary restenosis(6-9 month)