Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-01-01 @ 11:00 PM
Study NCT ID:
NCT02169258
Status:
UNKNOWN
Last Update Posted:
2015-09-25
First Post:
2014-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty
Sponsor:
National Cheng-Kung University Hospital
Organization:
Study Overview
Official Title:
Prognostic Impact of ROUtine Coronary CathETerization in Low Extremity ArTEry Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA Study)
Status:
UNKNOWN
Status Verified Date:
2015-09
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:
PIROUETTEPTA
Brief Summary:
1. The prevalence of significant and complex obstructive coronary artery disease (CAD) is high in patients who have low extremity artery disease (LEAD).
2. Long-term prognosis of LEAD undergoing percutaneous transluminal angioplasty (PTA) remains poor and CAD is an independent predictor of total mortality after PTA.
3. This prospective randomized controlled trial will evaluate the prognostic effects of routine versus selective coronary angiography before PTA for LEAD and elucidate the potential mechanism.
2. Long-term prognosis of LEAD undergoing percutaneous transluminal angioplasty (PTA) remains poor and CAD is an independent predictor of total mortality after PTA.
3. This prospective randomized controlled trial will evaluate the prognostic effects of routine versus selective coronary angiography before PTA for LEAD and elucidate the potential mechanism.
Detailed Description:
1. participants
1. eligible participants are randomly assigned to systemic strategy or selective strategy
* participants allocated to systemic strategy will receive routine coronary angiography before PTA without a previous non-invasive stress test
* subjects allocated to selective strategy will undergo non-invasive evaluation of possible myocardial ischemia by using dobutamine stress echocardiography (DSE) or dipyridamole thallium 201 myocardial perfusion scintigraphy (dTS) followed by coronary angiography if the test is positive for ischemia
2. participants who are not willing to be randomized will be included in the registration group
2. revascularization
1. a staged approach (myocardial revascularization first followed by PTA) and simultaneous approach (percutaneous coronary intervention immediately followed by PTA at the same time if clinically suitable) are both allowed
2. the duration from revascularization to PTA should be within 60 days
3. percutaneous coronary intervention is performed at the time of coronary angiography, using bare metal or drug-eluting stents
3. blood sampling, genotyping, and measurement of biomarkers and microRNA
a. bood samples (20 mL) are obtained from peripheral arteries in all study subjects before PTA and 10 mL after PTA and are prepared and stored for enzyme-linked immunosorbent assay (ELISA), genotyping and measurement of microRNAs in plasma and peripheral blood mononuclear cells
4. outcome follow-up a. clinical outcomes are obtained by chart review if the patient is still in the hospital and followed up by clinic visit, telephone call or direct contact with participants or subjects' family at 30 days after indexed PTA if the patient has been discharged from the hospital and every 6 months thereafter
1. eligible participants are randomly assigned to systemic strategy or selective strategy
* participants allocated to systemic strategy will receive routine coronary angiography before PTA without a previous non-invasive stress test
* subjects allocated to selective strategy will undergo non-invasive evaluation of possible myocardial ischemia by using dobutamine stress echocardiography (DSE) or dipyridamole thallium 201 myocardial perfusion scintigraphy (dTS) followed by coronary angiography if the test is positive for ischemia
2. participants who are not willing to be randomized will be included in the registration group
2. revascularization
1. a staged approach (myocardial revascularization first followed by PTA) and simultaneous approach (percutaneous coronary intervention immediately followed by PTA at the same time if clinically suitable) are both allowed
2. the duration from revascularization to PTA should be within 60 days
3. percutaneous coronary intervention is performed at the time of coronary angiography, using bare metal or drug-eluting stents
3. blood sampling, genotyping, and measurement of biomarkers and microRNA
a. bood samples (20 mL) are obtained from peripheral arteries in all study subjects before PTA and 10 mL after PTA and are prepared and stored for enzyme-linked immunosorbent assay (ELISA), genotyping and measurement of microRNAs in plasma and peripheral blood mononuclear cells
4. outcome follow-up a. clinical outcomes are obtained by chart review if the patient is still in the hospital and followed up by clinic visit, telephone call or direct contact with participants or subjects' family at 30 days after indexed PTA if the patient has been discharged from the hospital and every 6 months thereafter
Study Oversight
Has Oversight DMC:
False
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?: