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NCT Number: NCT03487432

A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions

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)).

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Key information

Conditions

Calcified Coronary Artery Disease (Grade 3) Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitäts-Herzzentrum Freiburg Bad Krozingen, Bad Krozingen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Super High-Pressure NC PTCA Balloon (OPN NC)

Device

Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty.

Scoring PTCA Balloon (NSE Alpha)

Device

Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty.

Primary outcomes

  1. Stent expansion index (SEI)

    Time frame: intraprocedural

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

Secondary outcomes

  1. Angiographic Success

    Time frame: intraprocedural

    'Angiographic Success', defined as the achievement of residual angiographic stenosis <30% of the target lesion in the presence of TIMI 3 flow

  2. Procedural Success

    Time frame: 30 days

    '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])

  3. Strategy Success

    Time frame: intraprocedural

    '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])

  4. Acute lumen gain,

    Time frame: intraprocedural

    Acute lumen gain, defined as minimal lumen diameter (MLD) post balloon angioplasty minus baseline MLD (mm)

  5. Complementary lesion preparations

    Time frame: intraprocedural

    Number of complementary lesion preparations with further devices (i.e. rotational atherectomy [RA])

  6. Rate of vessel perforation

    Time frame: intraprocedural

    Rate of vessel perforation

  7. Procedure duration

    Time frame: intraprocedural

    Procedure duration in min

  8. Contrast volume

    Time frame: intraprocedural

    Contrast volume in mL

Sponsors and collaborators

Lead sponsor

Deutsches Herzzentrum Muenchen

Other

Collaborators

  • SIS Medical AG

Registry information

Official study 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

Acronym: ISAR-CALC

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 4, 2018
Registry last updated
Nov 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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