Efficacy Study of Paclitaxel-eluting Balloon, -Stent vs. Plain Angioplasty for Drug-eluting Stent Restenosis

Phase 4

Completed

• Conditions: Heart Disease; Ischemia; Restenosis
• Interventions: Device: Taxus stent; Device: Conventional Balloon Catheter; Device: SeQuent Please

• Registration Number: NCT00987324
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-08-27
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Primary Completion: 2012-07
• Study Completion: 2013-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 402

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Paclitaxel-eluting stent	Taxus stent	Paclitaxel-eluting stent (Taxus)
Plain Balloon	Conventional Balloon Catheter	plain balloon angioplasty
Paclitaxel-eluting balloon	SeQuent Please	SeQuent Please

Primary Outcome Measures

Name	Time	Method
Percent in-segment diameter stenosis at follow-up angiography	6-8 months

Secondary Outcome Measures

Name	Time	Method
In-segment binary angiographic restenosis	6-8 months
Incidence of thrombosis	1 and 2 years
In-segment minimal luminal diameter	6-8 months
Combined incidence of death or myocardial infarction	1 and 2 years

Trial Locations

Locations (3)

Herz-Zentrum; 🇩🇪 Bad Krozingen, Germany

Deutsches Herzzentrum; 🇩🇪 Munich, Germany

1. Med. Klinik, Klinikum rechts der Isar; 🇩🇪 Munich, Bavaria, Germany