| 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 |
| 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 |
|---|---|
|
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.
|
| 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 | |||||||
|---|---|---|---|---|---|---|---|
| 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 |
|
||||||
| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures |
|
||||||
| 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
|
||||||
| 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 |
||||||
| 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.
|
||||||
| 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
|
||||||
| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
| 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 | ||||||