Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4

Phase 4

Completed

• Conditions: Stable Angina Pectoris; Acute Coronary Syndrome; Restenosis
• Interventions: Device: Paclitaxel Eluting Balloon + Scoring Balloon; Device: Paclitaxel Eluting Balloon

• Registration Number: NCT01632371
• Lead Sponsor: Deutsches Herzzentrum Muenchen

Brief Summary

The purpose of the study is to determine whether scoring balloon (SCB) plus paclitaxel-coated balloon (PCB) is superior to PCB alone for the treatment of restenosis within "limus"-eluting stents (LES)

Detailed Description

The optimal treatment of in-BMS-restenosis seems to be implantation of a DES which is supported by a large body of evidence. Nevertheless, several recent published studies have shown a substantial reduction in late lumen loss and angiographic restenosis using paclitaxel-coated balloons (PCB) for restenotic lesions. Given the increased world-wide use of DES and the use of DES in increasingly complex coronary disease patterns, the number of patients presenting with restenosis after DES implantation will further increase in the coming decade.

Data regarding the optimal treatment of in-DES-restenosis are very limited: Implanting a new DES for in-DES-restenosis has been reported to associate with repeat restenosis rates as high as 20%. In addition, an increased risk of stent thrombosis has been associated with complex stenting and with additional DES implantation. Thus, for lesions which develop restenosis after LES implantation, the optimal treatment strategy remains unknown.

Few results on small sample-size populations have been reported in patients treated with scoring or cutting balloon (SCB) technology for treatment of BMS restenosis as compared to plain balloon angioplasty. Moreover, the efficacy of SCB angioplasty in DES restenosis has not been adequately addressed. Furthermore, the potential additive benefit of SCB angioplasty in patients undergoing PCB therapy remains to be elucidated. The hypothesis behind this concept is that the application of SCB prior to deployment of PCB may increase the bioavailability of paclitaxel within the restenotic tissue, and therefore may increase the efficacy of PCB. There are numerous preclinical studies to support this hypothesis, which show that lesion preparation is an important pre-requisite for the effectiveness of PCB.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-26
• Study First Submitted QC: 2012-06-28
• Study First Posted: 2012-07-02
• Primary Completion: 2015-08
• Status Verified: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-18
• Last Update Posted: 2016-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 252

Inclusion Criteria

• Patients with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% restenosis after prior implantation of LES in native coronary vessels.
• Written, informed consent by the patient or her/his legally-authorized representative for participation in the study.
• In women with childbearing potential a negative pregnancy test is mandatory.

Exclusion Criteria

• Age < 18 years
• Cardiogenic shock
• Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
• 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.
• Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
• Contraindications to antiplatelet therapy, paclitaxel, stainless steel, cobalt, chrome
• Therapy including Lovastatin, Ciclosporin, Terfenadine, Midazolam, or Ondansetron
• Pregnancy (present, suspected or planned) or positive pregnancy test.
• Previous enrollment in this trial.
• 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 Balloon + Scoring Balloon	Paclitaxel Eluting Balloon + Scoring Balloon	Dilatation of the lesion with an Paclitaxel Eluting Balloon before the utilization of a Scoring Balloon
Paclitaxel Eluting Balloon	Paclitaxel Eluting Balloon	Paclitaxel Eluting Balloon

Primary Outcome Measures

Name	Time	Method
In-segment percent diameter stenosis	6-8 months	In-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography

Secondary Outcome Measures

Name	Time	Method
In-stent late lumen loss	6-8 months	The difference between minimal lumen diameter post-procedure and minimal lumen diameter at follow-up angiography
Target lesion thrombosis	1 and 2 years	Incidence of target lesion thrombosis at one and two years
In-segment binary angiographic restenosis	6-8 month	diameter stenosis ≥50% in the in-segment area (including the interventional area as well as 5 mm margins proximal and distal) at follow-up angiography
Death or myocardial infarction	1 and 2 years	Combined incidence of death or myocardial infarction at one and two year
Target lesion revascularization	1 and 2 years	Need for target lesion revascularization (TLR), defined as any revascularization procedure involving the target lesion due to luminal re-narrowing in the presence of symptoms or objective signs of ischemia at one and two year follow-up
OCT tissue characterization	6-8 months	Tissue characterization following application of SCB and PCB using OCT at 6 -8 months follow up

Trial Locations

Locations (2)

Deutsches Herzzentrum Muenchen; 🇩🇪 Munich, Bavaria, Germany

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