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

National Cheng-Kung University

Status: Unknown

Conditions: Coronary Artery Disease; Peripheral Artery Disease

Treatments: Procedure: Systemic Strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT02169258

B-BR-103-023

Details and patient eligibility

About

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.

Full 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

Enrollment: 700 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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700 participants in 3 patient groups, including a placebo group

Selective Strategy

Placebo Comparator group

Description:

non-invasive evaluation of possible myocardial ischemia by using DSE or dTS followed by coronary angiography if the test is positive for ischemia

Treatment:

Procedure: Systemic Strategy

Registry

No Intervention group

Description:

Clinical decisions are reached by consensus of operators, patients and family as usual care

Systemic Strategy

Active Comparator group

Description:

Routine coronary angiography before PTA without a previous non-invasive stress test

Treatment:

Procedure: Systemic Strategy