Ignite Creation Date:
2024-05-06 @ 3:09 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04531007
Status:
UNKNOWN
Last Update Posted:
2021-11-11
First Post:
2020-06-26
Brief Title:
Imaging and Physiology for Intermediate Left Main Stem Stenosis
Sponsor:
Instituto Dante Pazzanese de Cardiologia
Organization:
Instituto Dante Pazzanese de Cardiologia
Study Overview
Official Title:
Validation of Intravascular Imaging and Physiology for Intermediate Left Main Stem Stenosis With Downstream Coronary Lesions
Status:
UNKNOWN
Status Verified Date:
2021-11
Last Known Status:
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:
VIP-LMS
Brief Summary:
The present research aims to determine the impact of stenoses in downstream vessels on the FFR and iFR measurements of left main coronary artery LMCA stenoses of intermediate severity as determined by coronary angiography Anatomic metrics derived from intravascular imaging modalities of IVUS and optical coherence tomography OCT will also be validated using as the comparator the FFRtrue and iFRtrue measurements pf LMCA lesions
Detailed Description:
Accurate characterization of the functional significance of intermediate stenoses located in the left main coronary artery LMCA is of central relevance for decisions about the need of myocardial revascularization However the physiological assessment of such lesions by means of fractional flow reserve FFR measurements are affected by stenoses in the downstream vessels left anterior descending artery andor left circumflex artery which frequently coexist in series with LMCA lesions More recently introduced the instantaneous wave-free ratio iFR is a resting index that is less influenced by crosstalk between serial lesions and in theory could be more accurate for assessment of LMCA stenoses in the presence of downstream disease Nonetheless iFR has not been validated for assessment of LMCA lesions Due to the difficulty in interpreting FFR results the possibility of characterizing the atheroma type precisely estimate lesion severity and disease extension and distribution intravascular imaging especially intravascular ultrasound IVUS became an attractive alternative to assess LMCA lesions and guide the percutaneous treatment whenever this strategy is selected However most IVUS validations for LMCA stenosis assessment used FFR as the standard comparator which by itself has limited diagnostic ability in this anatomic scenario
Thus the main objective of the current research project is to determine the impact of stenoses in downstream vessels on FFR and iFR measurements of LMCA stenoses of intermediate severity as determined by coronary angiography The primary endpoint is the change delta in FFR and iFR values prior and after percutaneous treatment of downstream stenoses Assuming a change of 004 mmHg between the FFRpredicted and FFRtrue with a standard deviation of 004 mmHg and a change of 001 mmHg between iFRpredicted and iFRtrue with a standard deviation of 003 mmHg a total of 53 patients are needed to confirm the mean difference of 003 mmHg between iFR and FFR changes before and after treatment of downstream stenoses Anatomic metrics derived from intravascular imaging modalities of IVUS and optical coherence tomography OCT will also be validated using as the comparator the FFRtrue and iFRtrue measurements
Thus the main objective of the current research project is to determine the impact of stenoses in downstream vessels on FFR and iFR measurements of LMCA stenoses of intermediate severity as determined by coronary angiography The primary endpoint is the change delta in FFR and iFR values prior and after percutaneous treatment of downstream stenoses Assuming a change of 004 mmHg between the FFRpredicted and FFRtrue with a standard deviation of 004 mmHg and a change of 001 mmHg between iFRpredicted and iFRtrue with a standard deviation of 003 mmHg a total of 53 patients are needed to confirm the mean difference of 003 mmHg between iFR and FFR changes before and after treatment of downstream stenoses Anatomic metrics derived from intravascular imaging modalities of IVUS and optical coherence tomography OCT will also be validated using as the comparator the FFRtrue and iFRtrue measurements
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None