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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04014595
• Other study ID #: SK 110 -- 168/11
• Status: Active, not recruiting
• Start date: January 1, 2019
• Est. completion date: July 31, 2025

Study information

• Verified date: June 2022
• Source: Segeberger Kliniken GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 31, 2025
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

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.

Locations

Country	Name	City	State
Germany	Herzzentrum Segeberger Kliniken GmbH	Bad Segeberg

Sponsors (1)

Lead Sponsor	Collaborator
Segeberger Kliniken GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Rate of in-segment binary restenosis at 9 months in percent	In-segment binary restenosis at 9 months	9 months follow-up
Secondary	Rate of stent thrombosis in percent	Stent thrombosis	9 months, 1 and 2 years follow-up and final 5 years follow-up
Secondary	Rate of peri-procedural myocardial infarction in percent	Peri-procedural myocardial infarction	Peri-procedural
Secondary	Rate of vessel perforation in percent	Rate of vessel perforation	Peri-procedural
Secondary	Numerical procedural duration in min	Procedural duration	Peri-procedural
Secondary	Numerical contrast dye amount in ml	Procedural contrast dye amount	Peri-procedural