Instent Restenosis Clinical Trial
Official title:
The Valentines Trial
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.
n/a
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00481780 -
PTA vs. CB-PTA for Treatment of Femoropopliteal Artery In-Stent Restenosis
|
N/A |