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

Not Applicable

Completed

• Conditions: Coronary Atherosclerosis Due to Severely Calcified Coronary Lesion
• Interventions: Device: Cutting/Scoring Balloon; Device: Rotational Atherectomy

• Registration Number: NCT02502851
• Lead Sponsor: Segeberger Kliniken GmbH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2015-07-13
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-20
• Primary Completion: 2018-07
• Study Completion: 2019-10
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-31
• Last Update Posted: 2020-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. 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

2. 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

1. Clinical exclusion criteria

   • Myocardial infarction (within 1 week)
   • Decompensated heart failure
   • Limited long term prognosis due to other conditions

2. Angiographic exclusion criteria

   • Target lesion is in a coronary artery bypass graft
   • Target lesion is an in-stent restenosis
   • Target vessel thrombus

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cutting/Scoring Balloon	Cutting/Scoring Balloon	Calcified lesion preparation using cutting/scoring balloon followed by implantation of the ORSIRO sirolimus-eluting stent
Rotational Atherectomy	Rotational Atherectomy	Calcified lesion preparation using rotational atherectomy followed by implantation of the ORSIRO sirolimus-eluting stent

Primary Outcome Measures

Name	Time	Method
Strategy Success	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
In-Stent late lumen loss at 9 months	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 Outcome Measures

Name	Time	Method
In-segment binary restenosis at 9 months	9 months	In-segment binary restenosis (diameter stenosis ≥ 50%) at 9 months
Amount of contrast dye	Intraprocedural
Target vessel failure (TVF)	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
Stent thrombosis at 9 months, 1 and 2 years	9 months, 1 and 2 years	Stent thrombosis at 9 months, 1 and 2 years
Peri-procedural MI	within 72 hrs
Procedural duration	Intraproedural
In-segment late lumen loss at 9 months	9 months	In-segment late lumen loss (stent length + 5 mm on either side) at 9 months

Trial Locations

Locations (1)

Segeberger Kliniken GmbH; 🇩🇪 Bad Segeberg, Schleswig-Holstein, Germany