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Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5 (ISAR-DESIRE5)

Primary Purpose

Coronary Artery Disease, Restenoses, Coronary

Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Drug eluting stent (DES)
Drug coated ballloon (DCB)
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients with ischemic symptoms and/or evidence of myocardial ischemia
  2. Presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels.
  3. Availability of an OCT-pullback of the target lesion
  4. Written informed consent by the patient for participation in the study.
  5. Age ≥ 18 years

Exclusion Criteria:

  1. Cardiogenic shock
  2. Acute ST-elevation myocardial infarction within 48 hours from symptom onset.
  3. Target lesion located in left main trunk or bypass graft.
  4. Previous treatment of the target lesion due to restenosis.
  5. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min)
  6. Contraindications to any components of the investigational devices or dual antiplatelet therapy
  7. Pregnancy (present, suspected or planned) or positive pregnancy test.
  8. Previous enrollment in this trial or participation in any other study at the time of enrollment.
  9. Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance.
  10. Patient's inability to fully comply with the study protocol

Sites / Locations

  • Deutsches Herzzentrum MünchenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

homogenous

heterogenous

Arm Description

Stratification - homogenous pattern

Stratification - homogenous pattern

Outcomes

Primary Outcome Measures

Composite endpoint of major adverse cardiac event (MACE)
Composite endpoint of major adverse cardiac event (MACE) all-cause death myocardial infarction target lesion revascularization (TLR)

Secondary Outcome Measures

Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR
Individual endpoints of the composite endpoints
all-cause death myocardial infarction target lesion revascularization (TLR)
Stent thrombosis according to the ARC criteria
Safety endpoint: a composite endpoint of all-cause death and myocardial infarction

Full Information

First Posted
September 9, 2022
Last Updated
October 12, 2022
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
XClinical GmbH, Abbott, Institute of Medical Informatics, Statistics and Epidemiology, TU Munich
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1. Study Identification

Unique Protocol Identification Number
NCT05544864
Brief Title
Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5
Acronym
ISAR-DESIRE5
Official Title
Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 28, 2022 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
XClinical GmbH, Abbott, Institute of Medical Informatics, Statistics and Epidemiology, TU Munich

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The hypothesis of the study is, that there is a significant interaction in treatment effect between the OCT pattern of neointima (heterogeneous or homogeneous) and the type of percutaneous coronary intervention (drug-eluting stent or drug-coated balloon) in patients with in-stent restenosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Restenoses, Coronary

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
376 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
homogenous
Arm Type
Other
Arm Description
Stratification - homogenous pattern
Arm Title
heterogenous
Arm Type
Other
Arm Description
Stratification - homogenous pattern
Intervention Type
Device
Intervention Name(s)
Drug eluting stent (DES)
Intervention Description
DES-implantation with an everolimus-eluting stent (Xience, Abbott Vascular)
Intervention Type
Device
Intervention Name(s)
Drug coated ballloon (DCB)
Intervention Description
DCB angioplasty with a paclitaxel-coated balloon (Agent, Boston Scientific)
Primary Outcome Measure Information:
Title
Composite endpoint of major adverse cardiac event (MACE)
Description
Composite endpoint of major adverse cardiac event (MACE) all-cause death myocardial infarction target lesion revascularization (TLR)
Time Frame
24 months of clinical follow-up after randomization
Secondary Outcome Measure Information:
Title
Target lesion failure (TLF): a composite of cardiac death, target-vessel myocardial infarction and TLR
Time Frame
24 months of clinical follow-up after randomization
Title
Individual endpoints of the composite endpoints
Description
all-cause death myocardial infarction target lesion revascularization (TLR)
Time Frame
24 months of clinical follow-up after randomization
Title
Stent thrombosis according to the ARC criteria
Time Frame
24 months of clinical follow-up after randomization
Title
Safety endpoint: a composite endpoint of all-cause death and myocardial infarction
Time Frame
24 months of clinical follow-up after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with ischemic symptoms and/or evidence of myocardial ischemia Presence of ≥ 50% restenosis after prior implantation of drug-eluting stents in native coronary vessels. Availability of an OCT-pullback of the target lesion Written informed consent by the patient for participation in the study. Age ≥ 18 years Exclusion Criteria: Cardiogenic shock Acute ST-elevation myocardial infarction within 48 hours from symptom onset. Target lesion located in left main trunk or bypass graft. Previous treatment of the target lesion due to restenosis. Severe renal insufficiency (glomerular filtration rate ≤ 30 ml/min) Contraindications to any components of the investigational devices or dual antiplatelet therapy Pregnancy (present, suspected or planned) or positive pregnancy test. Previous enrollment in this trial or participation in any other study at the time of enrollment. Malignancies or other comorbid conditions with life expectancy less than 12 months or that may result in protocol non-compliance. Patient's inability to fully comply with the study protocol
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Wiebe, MD
Phone
+49 89 1218
Ext
2923
Email
wiebe@dhm.mhn.de
First Name & Middle Initial & Last Name or Official Title & Degree
Salvatore Cassese, MD, PHD
Phone
+49 89 1218
Ext
2764
Email
cassese@dhm.mhn.de
Facility Information:
Facility Name
Deutsches Herzzentrum München
City
Munich
ZIP/Postal Code
80636
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Wiebe, MD
Phone
+49 89 1218
Ext
2923
Email
wiebe@dhm.mhn.de
First Name & Middle Initial & Last Name & Degree
Salvatore Cassese, MD, PHD
Phone
+49 89 1218
Ext
2764
Email
cassese@dhm.mhn.de
First Name & Middle Initial & Last Name & Degree
Jens Wiebe, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Intracoronary Stenting and Restenosis - Randomized Trial of Drug-eluting Stent Implantation or Drug-coated Balloon Angioplasty According to Neointima Morphology in Drug-eluting Stent Restenosis 5

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