Skip to main content
OpenTrials
Completed

NCT Number: NCT02502851

The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC)

The primary objective of this study is to evaluate the success of lesion preparation with either rotational atherectomy or cutting/scoring balloons as well as the long term effects of a hybrid sirolimus-eluting stent in an angiographically well-defined group of patients with complex calcified coronary lesions.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Segeberger Kliniken GmbH

Bad Segeberg, Schleswig-Holstein, 23795, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical inclusion criteria
  • Age above 18 years and consentable
  • Angiographically proven coronary artery disease
  • Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
  • Written informed consent
  • Angiographic inclusion criteria
  • De-novo lesion in a native coronary artery
  • Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
  • Luminal diameter reduction of 50-100% by visual estimation
  • Severe calcification of the target lesion

Exclusion criteria

  • Clinical exclusion criteria
  • Myocardial infarction (within 1 week)
  • Decompensated heart failure
  • Limited long term prognosis due to other conditions
  • Angiographic exclusion criteria
  • Target lesion is in a coronary artery bypass graft
  • Target lesion is an in-stent restenosis
  • Target vessel thrombus

Treatment and study plan

Rotational atherectomy

Device

Calcified lesion preparation using rotational atherectomy before implantation of the Orsiro drug eluting stent

Cutting/Scoring Balloon

Device

Calcified lesion preparation using cutting/scoring balloons before implantation of the Orsiro drug eluting stent

Primary outcomes

  1. Strategy Success

    Time frame: Intraprocedural

    The primary endpoint will be 'Strategy Success' defined as successful stent delivery and expansion with attainment of < 20% in-stent residual stenosis of the target lesion in the presence of TIMI 3 flow without crossover or stent failure

  2. In-Stent late lumen loss at 9 months

    Time frame: 9 months

    Co-primary Endpoint: The in-stent late lumen loss at 9 months, defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD) and the in-stent MLD at 9-month followup angiography.

Secondary outcomes

  1. Target vessel failure (TVF)

    Time frame: 9 months, 1 year, 2 years

    Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction (MI; Q- or non-Q-wave) and clinically driven target vessel revascularization (TVR) at 9 months, 1 and 2 years

  2. In-segment late lumen loss at 9 months

    Time frame: 9 months

    In-segment late lumen loss (stent length + 5 mm on either side) at 9 months

  3. In-segment binary restenosis at 9 months

    Time frame: 9 months

    In-segment binary restenosis (diameter stenosis ≥ 50%) at 9 months

  4. Stent thrombosis at 9 months, 1 and 2 years

    Time frame: 9 months, 1 and 2 years

    Stent thrombosis at 9 months, 1 and 2 years

  5. Peri-procedural MI

    Time frame: within 72 hrs

  6. Procedural duration

    Time frame: Intraproedural

  7. Amount of contrast dye

    Time frame: Intraprocedural

Sponsors and collaborators

Lead sponsor

Segeberger Kliniken GmbH

Other

Registry information

Official study title

The Comparison of Strategies to PREPARE Severely CALCified Coronary Lesions Trial (PREPARE-CALC): A Prospective Randomized Controlled Trial of Rotational Atherectomy Versus Cutting/Scoring Balloon in Severely Calcified Coronary Lesions

Acronym: PREPARE-CALC

Important dates

Study start
2014
Primary completion
2018
Study completion
2019
First posted
Jul 20, 2015
Registry last updated
Apr 1, 2020

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.