Instent Restenosis
Conditions
Keywords
Drug-eluting balloon, Paclitaxel, DIOR, short term registry, Valentines Trial, Drug-eluting balloon treatment of in-stent restenosis
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.
Interventions
DRUGPaclitaxel
Paclitaxel-coated balloon (3 µg/mm2)
Sponsors
Eurocor GmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical success at 6-9 month defined as freedom from MACE, death, MI,TLR and stent thrombosis | 6-9 month |
Secondary
| Measure | Time frame |
|---|---|
| In-stent and in-segment late loss and binary restenosis | 6-9 month |
Countries
Germany, Italy, Netherlands
Outcome results
None listed