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

This study is currently recruiting participants.
Verified July 2012 by Deutsches Herzzentrum Muenchen
Sponsor:
Collaborator:
Biotronik AG
Information provided by (Responsible Party):
Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier:
NCT01632371
First received: June 26, 2012
Last updated: July 4, 2012
Last verified: July 2012
History of Changes
  Purpose

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 Intervention Phase
Restenosis
Stable Angina Pectoris
Acute Coronary Syndrome
 Device: Paclitaxel Eluting Balloon + Scoring Balloon
Device: Paclitaxel Eluting Balloon
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Angina
Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by Deutsches Herzzentrum Muenchen:

Primary Outcome Measures:
  • In-segment percent diameter stenosis [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
    In-segment percent diameter stenosis (%DS) at 6-8 month follow-up angiography


Secondary Outcome Measures:
  • In-stent late lumen loss [ Time Frame: 6-8 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Combined incidence of death or myocardial infarction at one and two year

  • Target lesion revascularization [ Time Frame: 1 and 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Incidence of target lesion thrombosis at one and two years

  • OCT tissue characterization [ Time Frame: 6-8 months ] [ Designated as safety issue: Yes ]
    Tissue characterization following application of SCB and PCB using OCT at 6 -8 months follow up


Estimated Enrollment: 250
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01632371

Contacts
Contact: Adnan Kastrati, MD kastrati@dhm.mhn.de
Contact: Robert Byrne, MB PhD byrne@dhm.mhn.de

Locations
Germany
Deutsches Herzzentrum Muenchen Recruiting
Munich, Bavaria, Germany, 80636
Contact: Robert Byrne, MB PhD         byrne@dhm.mhn.de    
Contact: Michael Joner, MD         joner@dhm.mhn.de    
Sub-Investigator: Adnan Kastrati, MD            
Principal Investigator: Robert Byrne, MB PhD            
Sub-Investigator: Michael Joner, MD            
Sub-Investigator: Salvatore Cassesse, MD            
Sub-Investigator: Sebastian Kufner, MD            
Sub-Investigator: Tobias R Koppara, MD            
Sub-Investigator: Martin Orban, MD            
1. Med. Klinik am Klinikum rechts der Isar der TU Muenchen Recruiting
Munich, Bavaria, Germany, 81675
Contact: Karl-Ludwig Laugwitz, MD         klaugwitz@med1.med.tum.de    
Principal Investigator: Karl-Ludwig Laugwitz, MD            
Sub-Investigator: Tareq Ibrahim, MD            
Sub-Investigator: Simon Schneider, MD            
Sub-Investigator: Stefanie Schulz, MD            
Sponsors and Collaborators
Deutsches Herzzentrum Muenchen
Biotronik AG
Investigators
Study Chair: Adnan Kastrati, MD Deutsches Herzzentrum Munich
Principal Investigator: Robert Byrne, MB PhD Deutsches Herzzentrum Munich
  More Information

No publications provided

Responsible Party: Deutsches Herzzentrum Muenchen
ClinicalTrials.gov Identifier: NCT01632371     History of Changes
Other Study ID Numbers: GE IDE NO. S00112, CIV-12-05-006401
Study First Received: June 26, 2012
Last Updated: July 4, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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:
Angina Pectoris
Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
 Paclitaxel
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013