Clinical trial NCT04014595: PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons
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)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: Calcified coronary lesions
Lead sponsor: Segeberger Kliniken GmbH
Sponsor class: OTHER
First posted: 2019-07-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary endpoint: Numerical in-stent acute lumen gain in mm
timeFrame: At the end of the index procedure
measure: Co-primary OCT endpoint: Ratio of stent expansion index (SEI)
timeFrame: At the end of the index procedure
Secondary outcomes:
measure: Numerical in-stent late lumen loss at 9 month follow-up angiography in mm
timeFrame: 9 months follow-up
measure: Rate of angiographic success in percent
timeFrame: Peri-procedural
measure: Rate of strategy success in percent
timeFrame: Peri-procedural
measure: Rate of target vessel failure in percent
timeFrame: 9 months, 1 and 2 years follow-up
measure: Rate of in-segment binary restenosis at 9 months in percent
timeFrame: 9 months follow-up
measure: Rate of stent thrombosis in percent
timeFrame: 9 months, 1 and 2 years follow-up and final 5 years follow-up
measure: Rate of peri-procedural myocardial infarction in percent
timeFrame: Peri-procedural
measure: Rate of vessel perforation in percent
timeFrame: Peri-procedural
measure: Numerical procedural duration in min
timeFrame: Peri-procedural
measure: Numerical contrast dye amount in ml
timeFrame: Peri-procedural
Other outcomes:
measure: Ratio of OCT-measured stent excentricity index
timeFrame: Intra-procedural
Locations:
city: Bad Segeberg
country: Germany
facility: Herzzentrum Segeberger Kliniken GmbH
Study officials:
affiliation: Herzzentrum Segeberger Kliniken GmbH
name: Gert Richardt, Prof.
role: STUDY_CHAIR
References: