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A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions (ISAR-CALC)

Primary Purpose

Calcified Coronary Artery Disease (Grade 3)

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Super High-Pressure NC PTCA Balloon (OPN NC)
Scoring PTCA Balloon (NSE Alpha)
Sponsored by
Deutsches Herzzentrum Muenchen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcified Coronary Artery Disease (Grade 3)

Eligibility Criteria

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

Inclusion Criteria:

  • Age above 18 years and consentable;
  • Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia;
  • Angiographically-proven coronary artery disease;
  • De novo lesion in a native coronary artery;
  • Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation;
  • Calcification of the target lesion as determined by angiography (grade 3);
  • Unsuccessful lesion preparation (<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty
  • Written informed consent.

Exclusion Criteria:

  • Myocardial infarction (within 1 week);
  • Limited long-term prognosis due to other conditions;
  • Target lesion is in a coronary artery bypass graft;
  • Target lesion is an in-stent restenosis;
  • Target lesion is aorto-ostial;
  • Target vessel thrombus.

Sites / Locations

  • Universitäts-Herzzentrum Freiburg Bad Krozingen
  • Segeberger Kliniken GmbH
  • Herzzentrum Leipzig
  • Deutsches Herzzentrum Muenchen
  • Luzerner Kantonsspital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

OPN NC

NSE Alpha

Arm Description

Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC)

Patients receiving a Scoring PTCA Balloon (NSE Alpha)

Outcomes

Primary Outcome Measures

Stent expansion index (SEI)
Stent expansion index (SEI), defined as minimum stent area divided by mean reference area in an optical coherence tomography (OCT) quantitative analysis

Secondary Outcome Measures

Angiographic Success
'Angiographic Success', defined as the achievement of residual angiographic stenosis <30% of the target lesion in the presence of TIMI 3 flow
Procedural Success
'Procedural Success', defined as the achievement of angiographic success without any MACE, defined as cardiac death, target vessel related myocardial infarction and repeat revascularization (PTCA/PCI or coronary artery bypass graft [CABG])
Strategy Success
'Strategy Success' defined as procedural success using the assigned study device and stent, without requirement for lesion preparations with further devices (i.e. rotational atherectomy [RA])
Acute lumen gain,
Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm)
Complementary lesion preparations
Number of complementary lesion preparations with further devices (i.e. rotational atherectomy [RA])
Rate of vessel perforation
Rate of vessel perforation
Procedure duration
Procedure duration in min
Contrast volume
Contrast volume in mL

Full Information

First Posted
March 23, 2018
Last Updated
November 21, 2019
Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
SIS Medical AG
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1. Study Identification

Unique Protocol Identification Number
NCT03487432
Brief Title
A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions
Acronym
ISAR-CALC
Official Title
A ComparIson of Strategies to Prepare Severely Calcified Coronary Lesions - A Prospective Randomized Controlled Trial of Super High-Pressure NC PTCA Balloon Versus Scoring PTCA Balloon in Severely Calcified Coronary Lesions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
July 20, 2018 (Actual)
Primary Completion Date
September 23, 2019 (Actual)
Study Completion Date
October 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Deutsches Herzzentrum Muenchen
Collaborators
SIS Medical AG

4. Oversight

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

5. Study Description

Brief Summary
The objective of this prospective, multicenter, randomized, open-label trial is to evaluate the completeness of stent expansion following a strategy of lesion preparation with either a Super High-Pressure NC PTCA Balloon (OPN NC) or a Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty in an angiographically well-defined group of patients with severely calcified coronary lesions (grade 3) undergoing coronary stent implantation (SYNERGY everolimus-eluting stent (EES)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcified Coronary Artery Disease (Grade 3)

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
OPN NC
Arm Type
Experimental
Arm Description
Patients receiving a Super High-Pressure NC PTCA Balloon (OPN NC)
Arm Title
NSE Alpha
Arm Type
Experimental
Arm Description
Patients receiving a Scoring PTCA Balloon (NSE Alpha)
Intervention Type
Device
Intervention Name(s)
Super High-Pressure NC PTCA Balloon (OPN NC)
Intervention Description
Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty.
Intervention Type
Device
Intervention Name(s)
Scoring PTCA Balloon (NSE Alpha)
Intervention Description
Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty.
Primary Outcome Measure Information:
Title
Stent expansion index (SEI)
Description
Stent expansion index (SEI), defined as minimum stent area divided by mean reference area in an optical coherence tomography (OCT) quantitative analysis
Time Frame
intraprocedural
Secondary Outcome Measure Information:
Title
Angiographic Success
Description
'Angiographic Success', defined as the achievement of residual angiographic stenosis <30% of the target lesion in the presence of TIMI 3 flow
Time Frame
intraprocedural
Title
Procedural Success
Description
'Procedural Success', defined as the achievement of angiographic success without any MACE, defined as cardiac death, target vessel related myocardial infarction and repeat revascularization (PTCA/PCI or coronary artery bypass graft [CABG])
Time Frame
30 days
Title
Strategy Success
Description
'Strategy Success' defined as procedural success using the assigned study device and stent, without requirement for lesion preparations with further devices (i.e. rotational atherectomy [RA])
Time Frame
intraprocedural
Title
Acute lumen gain,
Description
Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm)
Time Frame
intraprocedural
Title
Complementary lesion preparations
Description
Number of complementary lesion preparations with further devices (i.e. rotational atherectomy [RA])
Time Frame
intraprocedural
Title
Rate of vessel perforation
Description
Rate of vessel perforation
Time Frame
intraprocedural
Title
Procedure duration
Description
Procedure duration in min
Time Frame
intraprocedural
Title
Contrast volume
Description
Contrast volume in mL
Time Frame
intraprocedural

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age above 18 years and consentable; Persistent angina symptoms despite optimal medical therapy and/or evidence of inducible ischemia; Angiographically-proven coronary artery disease; De novo lesion in a native coronary artery; Target reference vessel diameter between 2.25 and 4.00 mm by visual estimation; Calcification of the target lesion as determined by angiography (grade 3); Unsuccessful lesion preparation (<30% reduction of baseline diameter stenosis) with conventional NC balloon angioplasty Written informed consent. Exclusion Criteria: Myocardial infarction (within 1 week); Limited long-term prognosis due to other conditions; Target lesion is in a coronary artery bypass graft; Target lesion is an in-stent restenosis; Target lesion is aorto-ostial; Target vessel thrombus.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A Byrne, MD BCh PhD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Salvatore Cassese, MD PhD
Organizational Affiliation
Deutsches Herzzentrum Muenchen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäts-Herzzentrum Freiburg Bad Krozingen
City
Bad Krozingen
Country
Germany
Facility Name
Segeberger Kliniken GmbH
City
Bad Segeberg
Country
Germany
Facility Name
Herzzentrum Leipzig
City
Leipzig
Country
Germany
Facility Name
Deutsches Herzzentrum Muenchen
City
Muenchen
Country
Germany
Facility Name
Luzerner Kantonsspital
City
Luzern
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No

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A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions

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