Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty

Coronary Artery Disease Clinical Trial

— PIROUETTEPTA  

Official title:

Prognostic Impact of ROUtine Coronary CathETerization in Low Extremity ArTEry Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02169258
• Other study ID #: B-BR-103-023
• Status: Recruiting
• Phase: N/A
• First received: June 19, 2014
• Last updated: September 23, 2015
• Start date: June 2014
• Est. completion date: December 2018

Study information

• Verified date: September 2015
• Source: National Cheng-Kung University Hospital
• Contact: Ting-Hsing Chao, MD
• Phone: 886-6-2353535
• Email: chaoth[@]mail.ncku.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

Procedure:
• Systemic Strategy
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.

Locations

Country	Name	City	State
Taiwan	National Cheng Kung University Hospital	Tainan

Sponsors (8)

Lead Sponsor	Collaborator
National Cheng-Kung University Hospital	Buddhist Tzu Chi General Hospital, E-DA Hospital, Far Eastern Memorial Hospital, Kaohsiung Medical University, National Taiwan University Hospital, Tainan Municipal Hospital, University of Alberta

Country where clinical trial is conducted

Taiwan, 

References & Publications (3)

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. — View Citation

Duran NE, Duran I, Gürel E, Gündüz S, Göl 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to death from any cause	total mortality	Up to 48 months	No
Other	Time to congestive heart failure requiring hospitalization	congestive heart failure requiring hospitalization	Up to 48 months	No
Other	Time to any coronary revascularization	planned or unplanned coronary revascularization	Up to 48 months	No
Primary	Time to Composite of Major Adverse Cardiac Event (MACE)	cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization	up to 48 months	No
Secondary	MACE between the Screening and 30 days after PTA	cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization	30 days after indexed PTA	No
Secondary	Time to Composite of major coronary events	fatal or nonfatal myocardial infarction, recurrent angina pectoris, and any unplanned coronary revascularization	Up to 48 months	No