Condition or disease | Intervention/treatment |
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Coronary Artery Disease | Procedure: Rotational atherectomy in combination with cutting balloon |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
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 : | March 31, 2021 |
Estimated Study Completion Date : | July 31, 2022 |
Group/Cohort | Intervention/treatment |
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Rotational atherectomy + Cutting Balloon
Rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions
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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.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Clinical inclusion criteria
Angiographic inclusion criteria
Exclusion Criteria:
Clinical exclusion criteria
Angiographic exclusion criteria
Germany | |
Herzzentrum Segeberger Kliniken GmbH | |
Bad Segeberg, Germany, 23795 |
Study Chair: | Gert Richardt, Prof. | Herzzentrum Segeberger Kliniken GmbH |
Tracking Information | |||||||
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First Submitted Date | June 28, 2019 | ||||||
First Posted Date | July 10, 2019 | ||||||
Last Update Posted Date | October 22, 2020 | ||||||
Actual Study Start Date | January 1, 2019 | ||||||
Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||||||
Current Other Pre-specified Outcome Measures |
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
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Original Other Pre-specified Outcome Measures | Same as current | ||||||
Descriptive Information | |||||||
Brief Title | 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) | ||||||
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 Type | Observational [Patient Registry] | ||||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | 2 Years | ||||||
Biospecimen | Not Provided | ||||||
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. | ||||||
Condition | 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.
|
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Study Groups/Cohorts | Rotational atherectomy + Cutting Balloon
Rotational atherectomy in combination with cutting balloon in severely calcified coronary lesions
Intervention: Procedure: Rotational atherectomy in combination with cutting balloon
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Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||
Recruitment Status | Active, not recruiting | ||||||
Estimated Enrollment |
100 | ||||||
Original Estimated Enrollment | Same as current | ||||||
Estimated Study Completion Date | July 31, 2022 | ||||||
Estimated Primary Completion Date | March 31, 2021 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria |
Inclusion Criteria: Clinical inclusion criteria
Angiographic inclusion criteria
Exclusion Criteria: Clinical exclusion criteria
Angiographic exclusion criteria
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers | No | ||||||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries | Germany | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number | NCT04014595 | ||||||
Other Study ID Numbers | SK 110 -- 168/11 | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement | Not Provided | ||||||
Responsible Party | Segeberger Kliniken GmbH | ||||||
Study Sponsor | Segeberger Kliniken GmbH | ||||||
Collaborators | Not Provided | ||||||
Investigators |
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PRS Account | Segeberger Kliniken GmbH | ||||||
Verification Date | October 2020 |