Ignite Creation Date:
2025-12-24 @ 2:05 PM
Ignite Modification Date:
2026-02-25 @ 7:21 PM
Study NCT ID:
NCT04014595
Status:
UNKNOWN
Last Update Posted:
2022-06-08
First Post:
2019-06-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREPARE-CALC-COMBO: Severely Calcified Coronary Lesions Prepared With Rotational Atherectomy and Modified Balloons
Sponsor:
Segeberger Kliniken GmbH
Organization:
Study Overview
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)
Status:
UNKNOWN
Status Verified Date:
2022-06
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: