This trial has been completed.

Conditions restenosis, stable angina pectoris, acute coronary syndrome
Treatments paclitaxel eluting balloon + scoring balloon, paclitaxel eluting balloon
Phase phase 4
Sponsor Deutsches Herzzentrum Muenchen
Collaborator Biotronik AG
Start date June 2012
End date August 2015
Trial size 252 participants
Trial identifier NCT01632371, CIV-12-05-006401, GE IDE NO. S00112


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)

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Dilatation of the lesion with an Paclitaxel Eluting Balloon before the utilization of a Scoring Balloon
paclitaxel eluting balloon + scoring balloon
Scoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy
(Active Comparator)
Paclitaxel Eluting Balloon
paclitaxel eluting balloon
Standard balloon lesion predilation; paclitaxel-eluting balloon therapy

Primary Outcomes

In-segment percent diameter stenosis
time frame: 6-8 months

Secondary Outcomes

In-stent late lumen loss
time frame: 6-8 months
In-segment binary angiographic restenosis
time frame: 6-8 month
Death or myocardial infarction
time frame: 1 and 2 years
Target lesion revascularization
time frame: 1 and 2 years
Target lesion thrombosis
time frame: 1 and 2 years
OCT tissue characterization
time frame: 6-8 months

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title ISAR-DESIRE 4: Randomized Trial Of Scoring Balloon in Patients With Restenosis in "Limus"-Eluting Coronary Stents Undergoing Angioplasty With Paclitaxel-Coated Balloon
Principal investigator Robert Byrne, MB PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Deutsches Herzzentrum Muenchen.