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

Active, not recruiting

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Rotational atherectomy in combination with cutting balloon

• Registration Number: NCT04014595
• Lead Sponsor: Segeberger Kliniken GmbH

Brief Summary

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

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 Timeline

• Study Start: 2019-01-01
• Study First Submitted: 2019-06-28
• Study First Submitted QC: 2019-07-09
• Study First Posted: 2019-07-10
• Primary Completion: 2021-03-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-03
• Last Update Posted: 2022-06-08
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rotational atherectomy + Cutting Balloon	Rotational atherectomy in combination with cutting balloon	Rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions

Primary Outcome Measures

Name	Time	Method
Primary endpoint: Numerical in-stent acute lumen gain in mm	At the end of the index procedure	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.
Co-primary OCT endpoint: Ratio of stent expansion index (SEI)	At the end of the index procedure	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

Secondary Outcome Measures

Name	Time	Method
Numerical in-stent late lumen loss at 9 month follow-up angiography in mm	9 months follow-up	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.
Rate of angiographic success in percent	Peri-procedural	'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.
Rate of in-segment binary restenosis at 9 months in percent	9 months follow-up	In-segment binary restenosis at 9 months
Rate of strategy success in percent	Peri-procedural	'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.
Rate of target vessel failure in percent	9 months, 1 and 2 years follow-up	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.
Rate of peri-procedural myocardial infarction in percent	Peri-procedural	Peri-procedural myocardial infarction
Numerical procedural duration in min	Peri-procedural	Procedural duration
Numerical contrast dye amount in ml	Peri-procedural	Procedural contrast dye amount
Rate of stent thrombosis in percent	9 months, 1 and 2 years follow-up and final 5 years follow-up	Stent thrombosis
Rate of vessel perforation in percent	Peri-procedural	Rate of vessel perforation

Trial Locations

Locations (1)

Herzzentrum Segeberger Kliniken GmbH; 🇩🇪 Bad Segeberg, Germany