Treatment of Coronary In-Stent Restenosis

Restenosis Clinical Trial

— TIS  

Official title:

Prospective Randomised Study Comparing Efficacy of Treatment Coronary In-stent Restenosis Using Drug Eluting Paclitaxel-coated Balloon and Drug Eluting Stent With Everolimus.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01735825
• Other study ID #: FNO-KVO 631/2011 Pleva
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: June 2018

Study information

• Verified date: December 2022
• Source: University Hospital Ostrava
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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). 3-year long term clinical follow-up of iopromide-coated PEB and EES arms was performed. All clinical MACE (CV death, AMI and TVR) were recorded. Subanalysis of seal-wing PEB arm comparrng the treatment of BMS and DES-ISR was added.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: June 2018
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Restenosis

Intervention

Device:
• paclitaxel-coated balloon catheter with Iopromide coating
Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter
• drug eluting stent with everolimus
Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus
• seal-wing paclitaxel-eluting balloon catheter
Patients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter

Locations

Country	Name	City	State
Czechia	University Hospital	Ostrava

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Ostrava

Country where clinical trial is conducted

Czechia, 

References & Publications (1)

1.TAXUS III Trial: In-Stent Restenosis Treated With Stent-Based Delivery of Paclitaxel Incorporated in a Slow-Release Polymer Formulation J. van der Giessen, Circulation 2003,107:559-564: 2.Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial. Kastrati A,JAMA 2005;293:165-71 3.Treatment of coronary in-stent restenosis with a paclitaxel-coated ballon catheter, B.Scheller, NEJM,355;20,Nov 16,2006 4.Randomized Trial of Paclitaxel- Versus Sirolimus-Eluting Stents for Treatment of Coronary Restenosis in Sirolimus-Eluting Stents The ISAR-DESIRE 2 Study. Mehilli J, J Am Coll Cardiol 2010 Mar 5 5.Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease. Stone GW,. N Engl J Med 2010 May 6;362:1663-74 6.Angiogaphic surrogate end points in drug-eluting stent trials, S.J.Pocock, JACC, Vol 51,No 1,2008

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Binary restenosis	Binary restenosis is defined as a > 50% diameter stenosis at angiographic follow-up.	12 month
Primary	Late lumen loss	Late loss was defined as the minimal vessel lumen diameter immediately after the procedure minus the lumen diameter at angiographic follow-up	12 month
Secondary	Major Adverse Cardiac Events	Major Adverse Cardiac Events are defined as cardiovascular death, acute myocardial infarction or target vessel revascularisation	12 month