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

NCT ID: NCT01632371

Last Updated: 2016-11-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 252 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-11-30

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.

Conditions

Restenosis; Stable Angina Pectoris; Acute Coronary Syndrome

Keywords

In-stent Restenosis; Drug Eluting Stent; Paclitaxel Coated Balloon; Scoring Balloon; Cutting Balloon; Angiographic follow-up; Optical coherence tomography (OCT)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paclitaxel Eluting Balloon + Scoring Balloon

Dilatation of the lesion with an Paclitaxel Eluting Balloon before the utilization of a Scoring Balloon

Group Type: EXPERIMENTAL

Paclitaxel Eluting Balloon + Scoring Balloon

Intervention Type: DEVICE

Scoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy

Paclitaxel Eluting Balloon

Paclitaxel Eluting Balloon

Group Type: ACTIVE_COMPARATOR

Paclitaxel Eluting Balloon

Intervention Type: DEVICE

Standard balloon lesion predilation; paclitaxel-eluting balloon therapy

Interventions

Paclitaxel Eluting Balloon + Scoring Balloon

Scoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy

Intervention Type: DEVICE

Paclitaxel Eluting Balloon

Standard balloon lesion predilation; paclitaxel-eluting balloon therapy

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biotronik AG

INDUSTRY

Sponsor Role: collaborator

Deutsches Herzzentrum Muenchen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adnan Kastrati, MD

Role: STUDY_CHAIR

Deutsches Herzzentrum Munich

Robert Byrne, MB PhD

Role: PRINCIPAL_INVESTIGATOR

Deutsches Herzzentrum Munich

Locations

Deutsches Herzzentrum Muenchen

Munich, Bavaria, Germany

1. Med. Klinik am Klinikum rechts der Isar der TU Muenchen

Munich, Bavaria, Germany

Countries

Germany

References

Kufner S, Joner M, Schneider S, Tolg R, Zrenner B, Repp J, Starkmann A, Xhepa E, Ibrahim T, Cassese S, Fusaro M, Ott I, Hengstenberg C, Schunkert H, Abdel-Wahab M, Laugwitz KL, Kastrati A, Byrne RA; ISAR-DESIRE 4 Investigators. Neointimal Modification With Scoring Balloon and Efficacy of Drug-Coated Balloon Therapy in Patients With Restenosis in Drug-Eluting Coronary Stents: A Randomized Controlled Trial. JACC Cardiovasc Interv. 2017 Jul 10;10(13):1332-1340. doi: 10.1016/j.jcin.2017.04.024.

Reference Type: DERIVED

PMID: 28683939 (View on PubMed)

Other Identifiers

CIV-12-05-006401

Identifier Type: OTHER

Identifier Source: secondary_id

GE IDE NO. S00112

Identifier Type: -

Identifier Source: org_study_id