PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons

The Evaluation of a Strategy to PREPARE Severely CALCified Coronary Lesions With a Combination Of Rotational Atherectomy and Modified BallOons Trial (PREPARE-CALC- COMBO)

A prospective single-arm trial of rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Procedure: Rotational atherectomy in combination with cutting balloon

Detailed Description

A prospective single-arm trial to evaluate the acute and long term efficacy of a combined strategy of lesion preparation with rotational atherectomy followed by cutting balloon and by hybrid sirolimus-eluting stent implantation in an angiographically well-defined group of patients with severely calcified coronary lesions.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• Germany
  • Bad Segeberg, Germany, 23795
    • Herzzentrum Segeberger Kliniken GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with coronary artery disease subjected to percutaneous revascularization of the native coronary arteries and fullfilling all of the inclusion criteria and none of the exclusion criteria.

Description

Inclusion Criteria:

Clinical inclusion criteria

1. Age above 18 years and consentable
2. Angiographically proven coronary artery disease
3. Anginal symptoms and/or reproducible ischemia in the target area by ECG, functional stress testing or fractional flow reserve
4. Written informed consent

Angiographic inclusion criteria

1. De-novo lesion in a native coronary artery
2. Target reference vessel diameter between 2.25 and 4.0 mm by visual estimation
3. Luminal diameter reduction of 50-100% by visual estimation
4. Severe calcification of the target lesion (for definition see appendix)

Exclusion Criteria:

Clinical exclusion criteria

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

Angiographic exclusion criteria

1. Target lesion is in a coronary artery bypass graft
2. Target lesion is an in-stent restenosis
3. Target vessel thrombus

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rotational atherectomy + Cutting Balloon; Rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions	Procedure: Rotational atherectomy in combination with cutting balloon; Treatment of severely calcified coronary lesion using rotational atherectomy followed by balloon angioplasty using a cutting balloon and Implantation of the hybrid sirolimus-eluting stent.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint: Numerical in-stent acute lumen gain in mm	The main angiographic endpoint will be in-stent acute lumen gain defined as minimal lumen diameter (MLD) in stent at the end of the index procedure minus baseline MLD.	At the end of the index procedure
Co-primary OCT endpoint: Ratio of stent expansion index (SEI)	The main OCT endpoint will be stent expansion index (SEI), defined as minimum stent area divided by mean reference area in optical coherence tomography (OCT) quantitative analysis at the end of the index procedure	At the end of the index procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Numerical in-stent late lumen loss at 9 month follow-up angiography in mm	In-stent late lumen loss at 9 month follow-up angiography defined as the difference between the postprocedure in-stent minimal lumen diameter (MLD)and the in-stent MLD at 9-month followup angiography will be adopted as a co-primary endpoint.	9 months follow-up
Rate of angiographic success in percent	'Angiographic 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.	Peri-procedural
Rate of strategy success in percent	'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 stent failure.	Peri-procedural
Rate of target vessel failure in percent	Target vessel failure (TVF) defined as a composite of cardiac death, target vessel related myocardial infarction and clinically driven target vessel revascularization at 9 months, 1 and 2 years.	9 months, 1 and 2 years follow-up
Rate of in-segment binary restenosis at 9 months in percent	In-segment binary restenosis at 9 months	9 months follow-up
Rate of stent thrombosis in percent	Stent thrombosis	9 months, 1 and 2 years follow-up and final 5 years follow-up
Rate of peri-procedural myocardial infarction in percent	Peri-procedural myocardial infarction	Peri-procedural
Rate of vessel perforation in percent	Rate of vessel perforation	Peri-procedural
Numerical procedural duration in min	Procedural duration	Peri-procedural
Numerical contrast dye amount in ml	Procedural contrast dye amount	Peri-procedural

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ratio of OCT-measured stent excentricity index	Defined as the ratio of minimal lumen diameter and the maximal lumen diameter per cross section at the end of index procedure	Intra-procedural

Collaborators and Investigators

• Sponsor: Segeberger Kliniken GmbH
• Investigators: Study Chair: Gert Richardt, Prof., Herzzentrum Segeberger Kliniken GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 31, 2021
• Study Completion (Anticipated): July 31, 2025

Study Registration Dates

• First Submitted: June 28, 2019
• First Submitted That Met QC Criteria: July 9, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): June 8, 2022
• Last Update Submitted That Met QC Criteria: June 3, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Calcified coronary lesions
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: SK 110 -- 168/11

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes