Overview

This trial has been completed.

Conditions heart disease, ischemia, restenosis
Treatments taxus stent, sequent please, conventional balloon catheter
Phase phase 4
Sponsor Deutsches Herzzentrum Muenchen
Start date July 2009
End date July 2012
Trial size 402 participants
Trial identifier NCT00987324, GE IDE NO. S02908

Summary

The purpose of this randomized study is to determine which treatment option, either paclitaxel-eluting balloon, paclitaxel-eluting stent or plain balloon angioplasty is the most effective in the treatment of restenosis after implantation of "Limus"-eluting stents, (LES).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Paclitaxel-eluting stent (Taxus)
taxus stent
Implantation of paclitaxel-eluting stent
(Active Comparator)
plain balloon angioplasty
conventional balloon catheter
Ryuijin, Trek
(Experimental)
SeQuent Please
sequent please
Dilation with SeQuent Please (paclitaxel-eluting balloon)

Primary Outcomes

Measure
Percent in-segment diameter stenosis at follow-up angiography
time frame: 6-8 months

Secondary Outcomes

Measure
In-segment minimal luminal diameter
time frame: 6-8 months
In-segment binary angiographic restenosis
time frame: 6-8 months
Combined incidence of death or myocardial infarction
time frame: 1 and 2 years
Incidence of thrombosis
time frame: 1 and 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels. 2. Written, informed consent by the patient or her/his legally-authorized representative for participation in the study. 3. In women with childbearing potential a negative pregnancy test is mandatory. Exclusion Criteria: 1. Age < 18 years. 2. Cardiogenic shock. 3. Acute ST-elevation myocardial infarction within 48 hours from symptom onset. 4. Target lesion located in the left main trunk or bypass graft. 5. Target lesion located in small vessel (vessel size < 2.0 mm). 6. Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance. 7. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min). 8. Contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome. 9. Pregnancy (present, suspected or planned) or positive pregnancy test. 10. Previous enrollment in this trial. 11. Patient's inability to fully comply with the study protocol.

Additional Information

Official title Randomized Trial of Paclitaxel-Eluting Balloon, Paclitaxel-Eluting Stent and Plain Balloon Angioplasty for Restenosis in "-Limus"-Eluting Coronary Stents
Principal investigator Julinda Mehilli, MD
Description The use of drug-eluting stents (DES) has led to a drastic reduction of restenosis rates compared to bare metal stents (BMS), but 5% to 10% of patients receiving DES are still in need of revascularization of the treated vessel. Two important families of drugs are used for stent coating: paclitaxel belonging to the taxane family, and the "limus"-family such as sirolimus, everolimus, zotarolimus, biolimus A9 and pimecrolimus. Data regarding the optimal treatment of in-DES-restenosis is very limited. Implanting a new DES for in-DES-restenosis has been reported to be associated with re-restenosis rates as high as 43%. Several recent well published studies have shown a substantial reduction of restenosis using paclitaxel-eluting balloons (PEB) for de-novo lesions and BMS-restenotic lesions. The objective of this randomized trial is to assess the hypothesis, that PEB are non-inferior to paclitaxel-eluting-stents (PES) for restenosis in "limus"-eluting-stents (LES), and both, PEB and PES, are superior to plain angioplasty in patients with restenosis after initial LES implantation.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Deutsches Herzzentrum Muenchen.