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

German Heart Center Munich

Status and phase

Completed

Phase 4

Conditions

Restenosis

Acute Coronary Syndrome

Stable Angina Pectoris

Treatments

Device: Paclitaxel Eluting Balloon + Scoring Balloon

Device: Paclitaxel Eluting Balloon

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01632371

GE IDE NO. S00112

CIV-12-05-006401 (Other Identifier)

Details and patient eligibility

About

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)

Full 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.

Enrollment

252 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.