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

This study has been completed.
Sponsor:
Collaborator:
Biotronik AG
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01632371
First received: June 26, 2012
Last updated: November 18, 2016
Last verified: November 2016
June 26, 2012
November 18, 2016
June 2012
August 2015   (Final data collection date for primary outcome measure)
In-segment percent diameter stenosis [ Time Frame: 6-8 months ]
In-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography
Same as current
Complete list of historical versions of study NCT01632371 on ClinicalTrials.gov Archive Site
  • In-stent late lumen loss [ Time Frame: 6-8 months ]
    The difference between minimal lumen diameter post-procedure and minimal lumen diameter at follow-up angiography
  • In-segment binary angiographic restenosis [ Time Frame: 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 [ Time Frame: 1 and 2 years ]
    Combined incidence of death or myocardial infarction at one and two year
  • Target lesion revascularization [ Time Frame: 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
  • Target lesion thrombosis [ Time Frame: 1 and 2 years ]
    Incidence of target lesion thrombosis at one and two years
  • OCT tissue characterization [ Time Frame: 6-8 months ]
    Tissue characterization following application of SCB and PCB using OCT at 6 -8 months follow up
Same as current
Not Provided
Not Provided
 
Intracoronary Stenting and Angiographic Results: Optimizing Treatment of Drug Eluting Stent In-Stent Restenosis 4
ISAR-DESIRE 4: Randomized Trial Of Scoring Balloon in Patients With Restenosis in "Limus"-Eluting Coronary Stents Undergoing Angioplasty With Paclitaxel-Coated Balloon
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)

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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Restenosis
  • Stable Angina Pectoris
  • Acute Coronary Syndrome
  • Device: Paclitaxel Eluting Balloon + Scoring Balloon
    Scoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy
  • Device: Paclitaxel Eluting Balloon
    Standard balloon lesion predilation; paclitaxel-eluting balloon therapy
  • Experimental: Paclitaxel Eluting Balloon + Scoring Balloon
    Dilatation of the lesion with an Paclitaxel Eluting Balloon before the utilization of a Scoring Balloon
    Intervention: Device: Paclitaxel Eluting Balloon + Scoring Balloon
  • Active Comparator: Paclitaxel Eluting Balloon
    Paclitaxel Eluting Balloon
    Intervention: Device: Paclitaxel Eluting Balloon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
252
November 2016
August 2015   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01632371
GE IDE NO. S00112
CIV-12-05-006401 ( Other Identifier: European Databank on Medical Devices (EUDAMED) )
No
Not Provided
Not Provided
Deutsches Herzzentrum Muenchen
Deutsches Herzzentrum Muenchen
Biotronik AG
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Munich
Principal Investigator: Robert Byrne, MB PhD Deutsches Herzzentrum Munich
Deutsches Herzzentrum Muenchen
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP