Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06507449
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-07-12
Brief Title:
The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Influence of Modifying Highly Calcified Coronary Lesions on Coronary Microcirculation
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-center three-arm study to evaluate the impact of severely calcified coronary lesions treatment on microvascular circulation We will enroll 30 conveniently sampled subjects assigned to one of three therapeutical methods lithotripsy super-high pressure balloon and orbital atherectomy prior to implantation of drug-eluting stents DES
Detailed Description:
This prospective non-randomized single-center study includes subjects who meet all of the inclusion and none of the exclusion criteria and sign the ICF 30 patients with severe coronary stenosis will be enrolled The severity will be assessed by Optical Coherence Tomography OCT based on the degree of calcification in the coronary lesion as defined by this protocol Subjects will be assigned to one of three arms lithotripsy super-high pressure balloon or orbital atherectomy followed by an implantation of drug-eluting stents DES The aposition and expansion of DES will be evaluated using OCT Patients will be followed through discharge 30 days and 12 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None