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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01632371
Recruitment Status : Completed
First Posted : July 2, 2012
Last Update Posted : November 21, 2016
Biotronik AG
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen

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)

Condition or disease Intervention/treatment Phase
Restenosis Stable Angina Pectoris Acute Coronary Syndrome Device: Paclitaxel Eluting Balloon + Scoring Balloon Device: Paclitaxel Eluting Balloon Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 252 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : June 2012
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Paclitaxel Eluting Balloon + Scoring Balloon
Dilatation of the lesion with an Paclitaxel Eluting Balloon before the utilization of a Scoring Balloon
Device: Paclitaxel Eluting Balloon + Scoring Balloon
Scoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy

Active Comparator: Paclitaxel Eluting Balloon
Paclitaxel Eluting Balloon
Device: Paclitaxel Eluting Balloon
Standard balloon lesion predilation; paclitaxel-eluting balloon therapy

Primary Outcome Measures :
  1. In-segment percent diameter stenosis [ Time Frame: 6-8 months ]
    In-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography

Secondary Outcome Measures :
  1. 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

  2. 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

  3. Death or myocardial infarction [ Time Frame: 1 and 2 years ]
    Combined incidence of death or myocardial infarction at one and two year

  4. 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

  5. Target lesion thrombosis [ Time Frame: 1 and 2 years ]
    Incidence of target lesion thrombosis at one and two years

  6. OCT tissue characterization [ Time Frame: 6-8 months ]
    Tissue characterization following application of SCB and PCB using OCT at 6 -8 months follow up

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01632371

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Deutsches Herzzentrum Muenchen
Munich, Bavaria, Germany, 80636
1. Med. Klinik am Klinikum rechts der Isar der TU Muenchen
Munich, Bavaria, Germany, 81675
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Biotronik AG
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Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Munich
Principal Investigator: Robert Byrne, MB PhD Deutsches Herzzentrum Munich

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Deutsches Herzzentrum Muenchen Identifier: NCT01632371    
Other Study ID Numbers: GE IDE NO. S00112
CIV-12-05-006401 ( Other Identifier: European Databank on Medical Devices (EUDAMED) )
First Posted: July 2, 2012    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Keywords provided by Deutsches Herzzentrum Muenchen:
In-stent Restenosis
Drug Eluting Stent
Paclitaxel Coated Balloon
Scoring Balloon
Cutting Balloon
Angiographic follow-up
Optical coherence tomography (OCT)
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Angina Pectoris
Angina, Stable
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Neurologic Manifestations
Signs and Symptoms
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action