TIS: Treatment of Coronary In-Stent Restenosis
Study Details
Study Description
Brief Summary
The purpose of this study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
In-stent restenosis after coronary angioplasty is currently one of the main limitations of this method, leading to a recurrence of exertional angina pectoris or manifesting as acute coronary syndrome. Histopathologic substrate of in-stent restenosis is neointimal hyperplasia.
Repeated plain balloon angioplasty or using cutting balloon catheters in the treatment of in-stent restenosis does not achieve satisfactory results. Brachytherapy, used in the past, it has also abandoned. The current treatment of in-stent restenosis is the use of drug eluting stents. Local drug released from these stents prevents new neointimal hyperplasia.This treatment carries the risk of late thrombosis (due to delayed neoendotelization) the stent struts and requires rigorous long-term dual antiplatelet therapy with the risk of bleeding complications. The drug-coated balloon catheters provide short-term penetration of the active substance into the vascular wall, leading to the inhibition of hyperproliferation vascular smooth muscle cells, but due to short-term effect they do not affect negatively stent struts neoendotelization. Comparable effects of in-stent restenosis therapy using paclitaxel releasing balloons was demonstrated in comparison with paclitaxel releasing stents, however, the development of drug eluting stents meanwhile progressed. The aim of our study is to compare efficacy of coronary in-stent restenosis therapy using drug eluting paclitaxel-coated balloon catheters with the latest generation of drug eluting stents releasing everolimus. Primary endpoint of our study is late lumen loss, because it represents accurate angiographic parameter predicting the need for repeat revascularisation and thus the clinical benefit for the patient.
The 3rd observational, non-randomised arm compares the treatment with seal-wing paclitaxel-eluting balloon with two randomised arms (PEB vs. EES).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: paclitaxel-coated balloon Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter (iopomide coating) |
Device: paclitaxel-coated balloon catheter with Iopromide coating
Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter
Other Names:
|
| Active Comparator: drug eluting stent Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus |
Device: drug eluting stent with everolimus
Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus
Other Names:
|
| Other: seal-wing paclitaxel-eluting balloon catheter Observational, non-randomised arm: Pts with ISR treated by seal-wing paclitaxel-eluting balloon catheter |
Device: seal-wing paclitaxel-eluting balloon catheter
Patients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Late lumen loss [12 month]
Late loss was defined as the minimal vessel lumen diameter immediately after the procedure minus the lumen diameter at angiographic follow-up
Secondary Outcome Measures
- Major Adverse Cardiac Events [12 month]
Major Adverse Cardiac Events are defined as cardiovascular death, acute myocardial infarction or target vessel revascularisation
Other Outcome Measures
- Binary restenosis [12 month]
Binary restenosis is defined as a > 50% diameter stenosis at angiographic follow-up.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
history of percutaneous coronary intervention with stent placement
-
verified coronary in-stent restenosis suitable for percutaneous re-intervention
-
signed informed consent
Exclusion Criteria:
-
contraindication to long term dual antiplatelet therapy
-
increased risk of bleeding
-
known generalized malignancy
-
pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University Hospital | Ostrava | Czech Republic | 708 52 |
Sponsors and Collaborators
- University Hospital Ostrava
Investigators
- Principal Investigator: Leos Pleva, M.D., Cardiovascular Department, University Hospital Ostrava, Czech Republic
Study Documents (Full-Text)
None provided.More Information
Publications
- FNO-KVO 631/2011 Pleva