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

Acute Coronary Syndrome Clinical Trial

— ISAR-DESIRE 4  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01632371
• Other study ID #: GE IDE NO. S00112
• Secondary ID: CIV-12-05-006401
• Status: Completed
• Phase: Phase 4
• First received: June 26, 2012
• Last updated: November 18, 2016
• Start date: June 2012
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Deutsches Herzzentrum Muenchen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 252
• Est. completion date: November 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Angina Pectoris
• Angina, Stable
• Restenosis
• Stable Angina Pectoris

Intervention

Device:
• Paclitaxel Eluting Balloon + Scoring Balloon
Scoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy
• Paclitaxel Eluting Balloon
Standard balloon lesion predilation; paclitaxel-eluting balloon therapy

Locations

Country	Name	City	State
Germany	1. Med. Klinik am Klinikum rechts der Isar der TU Muenchen	Munich	Bavaria
Germany	Deutsches Herzzentrum Muenchen	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Deutsches Herzzentrum Muenchen	Biotronik AG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-segment percent diameter stenosis	In-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography	6-8 months	No
Secondary	In-stent late lumen loss	The difference between minimal lumen diameter post-procedure and minimal lumen diameter at follow-up angiography	6-8 months	No
Secondary	In-segment binary angiographic restenosis	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	6-8 month	No
Secondary	Death or myocardial infarction	Combined incidence of death or myocardial infarction at one and two year	1 and 2 years	Yes
Secondary	Target lesion revascularization	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	1 and 2 years	No
Secondary	Target lesion thrombosis	Incidence of target lesion thrombosis at one and two years	1 and 2 years	Yes
Secondary	OCT tissue characterization	Tissue characterization following application of SCB and PCB using OCT at 6 -8 months follow up	6-8 months	Yes