- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02169258
Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTEPTA)
Prognostic Impact of ROUtine Coronary CathETerization in Low Extremity ArTEry Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA Study)
- The prevalence of significant and complex obstructive coronary artery disease (CAD) is high in patients who have low extremity artery disease (LEAD).
- Long-term prognosis of LEAD undergoing percutaneous transluminal angioplasty (PTA) remains poor and CAD is an independent predictor of total mortality after PTA.
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
participants
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
- participants who are not willing to be randomized will be included in the registration group
revascularization
- 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
- the duration from revascularization to PTA should be within 60 days
- percutaneous coronary intervention is performed at the time of coronary angiography, using bare metal or drug-eluting stents
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
- 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 Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ting-Hsing Chao, MD
- Phone Number: 2382 886-6-2353535
- Email: chaoth@mail.ncku.edu.tw
Study Locations
-
-
-
Tainan, Taiwan, 704
- Recruiting
- National Cheng Kung University Hospital
-
Contact:
- Ting-Hsing Chao, MD
- Phone Number: 2382 886-6-2353535
- Email: chaoth@mail.ncku.edu.tw
-
Principal Investigator:
- Cheng-Han Lee, MD/PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Known LEAD (documented by previous angiography or sonography performed by the operators) admitted for elective PTA
Exclusion Criteria:
- Known CAD or unstable angina within past 3 months
- Acute myocardial infarction within past 6 months
- Known CAD status posterior percutaneous coronary intervention or bypass surgery within past 6 months
- Planning to do bypass surgery for known LEAD\
- Pregnancy
- Documented active malignancy
- Needing emergency PTA
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Selective Strategy
non-invasive evaluation of possible myocardial ischemia by using DSE or dTS followed by coronary angiography if the test is positive for ischemia
|
Significant CAD needing further revascularization is defined as patients who have luminal stenosis > 70% of the major epicardial vessels and bypass graft vessel or their major branches (> 50% for left main trunk or in-stent restenotic lesion) with reference vessel larger than 2.5 mm in diameter and moderate area of vulnerable myocardium for ischemia.
Intermediate stenotic lesions should be determined if they are hemodynamic significant by fractional flow reserve (FFR) (<=0.8).
The choice of revascularization procedure, either percutaneous coronary intervention or coronary artery bypass surgery, depends on operator's or cardiovascular team's suggestion and patient's decision.
Other Names:
|
No Intervention: Registry
Clinical decisions are reached by consensus of operators, patients and family as usual care
|
|
Active Comparator: Systemic Strategy
Routine coronary angiography before PTA without a previous non-invasive stress test
|
Significant CAD needing further revascularization is defined as patients who have luminal stenosis > 70% of the major epicardial vessels and bypass graft vessel or their major branches (> 50% for left main trunk or in-stent restenotic lesion) with reference vessel larger than 2.5 mm in diameter and moderate area of vulnerable myocardium for ischemia.
Intermediate stenotic lesions should be determined if they are hemodynamic significant by fractional flow reserve (FFR) (<=0.8).
The choice of revascularization procedure, either percutaneous coronary intervention or coronary artery bypass surgery, depends on operator's or cardiovascular team's suggestion and patient's decision.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to Composite of Major Adverse Cardiac Event (MACE)
Time Frame: up to 48 months
|
cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization
|
up to 48 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MACE between the Screening and 30 days after PTA
Time Frame: 30 days after indexed PTA
|
cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization
|
30 days after indexed PTA
|
Time to Composite of major coronary events
Time Frame: Up to 48 months
|
fatal or nonfatal myocardial infarction, recurrent angina pectoris, and any unplanned coronary revascularization
|
Up to 48 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to death from any cause
Time Frame: Up to 48 months
|
total mortality
|
Up to 48 months
|
Time to congestive heart failure requiring hospitalization
Time Frame: Up to 48 months
|
congestive heart failure requiring hospitalization
|
Up to 48 months
|
Time to any coronary revascularization
Time Frame: Up to 48 months
|
planned or unplanned coronary revascularization
|
Up to 48 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Chang SH, Tsai YJ, Chou HH, Wu TY, Hsieh CA, Cheng ST, Huang HL. Clinical predictors of long-term outcomes in patients with critical limb ischemia who have undergone endovascular therapy. Angiology. 2014 Apr;65(4):315-22. doi: 10.1177/0003319713515544. Epub 2013 Dec 19.
- Monaco M, Stassano P, Di Tommaso L, Pepino P, Giordano A, Pinna GB, Iannelli G, Ambrosio G. Systematic strategy of prophylactic coronary angiography improves long-term outcome after major vascular surgery in medium- to high-risk patients: a prospective, randomized study. J Am Coll Cardiol. 2009 Sep 8;54(11):989-96. doi: 10.1016/j.jacc.2009.05.041.
- Duran NE, Duran I, Gurel E, Gunduz S, Gol G, Biteker M, Ozkan M. Coronary artery disease in patients with peripheral artery disease. Heart Lung. 2010 Mar-Apr;39(2):116-20. doi: 10.1016/j.hrtlng.2009.07.004.
- Chen IC, Lee CH, Chao TH, Tseng WK, Lin TH, Chung WJ, Li JK, Huang HL, Liu PY, Chao TK, Chu CY, Lin CC, Hsu PC, Lee WH, Lee PT, Li YH, Tseng SY, Tsai LM, Hwang JJ. Impact of routine coronary catheterization in low extremity artery disease undergoing percutaneous transluminal angioplasty: study protocol for a multi-center randomized controlled trial. Trials. 2016 Feb 29;17(1):112. doi: 10.1186/s13063-016-1237-0.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B-BR-103-023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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