PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons
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|ClinicalTrials.gov Identifier: NCT04014595|
Recruitment Status : Recruiting
First Posted : July 10, 2019
Last Update Posted : July 26, 2019
|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Procedure: Rotational atherectomy in combination with cutting balloon|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||100 participants|
|Target Follow-Up Duration:||2 Years|
|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)|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||January 31, 2020|
|Estimated Study Completion Date :||January 31, 2022|
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.
- Primary endpoint: Numerical in-stent acute lumen gain in mm [ Time Frame: 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) [ Time Frame: 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
- Numerical in-stent late lumen loss at 9 month follow-up angiography in mm [ Time Frame: 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 [ Time Frame: 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 strategy success in percent [ Time Frame: 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 [ Time Frame: 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 in-segment binary restenosis at 9 months in percent [ Time Frame: 9 months follow-up ]In-segment binary restenosis at 9 months
- Rate of stent thrombosis in percent [ Time Frame: 9 months, 1 and 2 years follow-up ]Stent thrombosis
- Rate of peri-procedural myocardial infarction in percent [ Time Frame: Peri-procedural ]Peri-procedural myocardial infarction
- Rate of vessel perforation in percent [ Time Frame: Peri-procedural ]Rate of vessel perforation
- Numerical procedural duration in min [ Time Frame: Peri-procedural ]Procedural duration
- Numerical contrast dye amount in ml [ Time Frame: Peri-procedural ]Procedural contrast dye amount
- Ratio of OCT-measured stent excentricity index [ Time Frame: Intra-procedural ]Defined as the ratio of minimal lumen diameter and the maximal lumen diameter per cross section at the end of index procedure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04014595
|Contact: Abdelhakim Allali, MD||+494551802 ext firstname.lastname@example.org|
|Contact: Ralph Tölg, P.D. , MD||+494551802 ext email@example.com|
|Herzzentrum Segeberger Kliniken GmbH||Recruiting|
|Bad Segeberg, Germany, 23795|
|Contact: Gert Richardt, MD +49 4551 802 4801 firstname.lastname@example.org|
|Study Chair:||Gert Richardt, Prof.||Herzzentrum Segeberger Kliniken GmbH|