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Status unknownNCT02169258PIROUETTEPTAUpdated Sep 25, 2015

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

An interventional study of Systemic Strategy in Peripheral Artery Disease and Coronary Artery Disease, sponsored by National Cheng-Kung University Hospital. Status unknown at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-09-25.

Sponsored by National Cheng-Kung University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
700
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.
Read the 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
02

Conditions studied

  • Peripheral Artery Disease
  • Coronary Artery Disease

Keywords

  • coronary artery disease
  • peripheral artery disease
  • percutaneous transluminal angioplasty
  • coronary angiography
  • revascularization
  • gene polymorphisms
  • microRNAs
03

In context

Coronary Artery Disease

5,598 studies on the registry are indexed under Coronary Artery Disease; 957 are open to participants now.

This study's planned enrollment of 700 is above the median of 124 across 3,436 interventional studies indexed under Coronary Artery Disease.

Browse Coronary Artery Disease studies →

Lead sponsor

National Cheng-Kung University Hospital is the lead sponsor of 268 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Known LEAD (documented by previous angiography or sonography performed by the operators) admitted for elective PTA

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
700 participants (estimated)

Study arms

  • 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

    Procedure: Systemic Strategy

  • 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

    Procedure: Systemic Strategy

Interventions

  • ProcedureSystemic 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.

    Also known as: Routine Coronary Angiography before PTA

06

What researchers measure

Primary outcomes

  1. Time to Composite of Major Adverse Cardiac Event (MACE)

    cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization

    Time frame: up to 48 months

Secondary outcomes

  1. MACE between the Screening and 30 days after PTA

    cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization

    Time frame: 30 days after indexed PTA

  2. Time to Composite of major coronary events

    fatal or nonfatal myocardial infarction, recurrent angina pectoris, and any unplanned coronary revascularization

    Time frame: Up to 48 months

Other outcomes

  1. Time to death from any cause

    total mortality

    Time frame: Up to 48 months

  2. Time to congestive heart failure requiring hospitalization

    congestive heart failure requiring hospitalization

    Time frame: Up to 48 months

  3. Time to any coronary revascularization

    planned or unplanned coronary revascularization

    Time frame: Up to 48 months

07

Study locations

1 of 1 sites recruiting
  • National Cheng Kung University Hospital
    Tainan, 704, Taiwan
    • Ting-Hsing Chao, MD · Contact · chaoth@mail.ncku.edu.tw · 886-6-2353535
    • Cheng-Han Lee, MD/PhD · Principal investigator
    Recruiting
08

References and documents

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. PubMed 24357434 ↗
  • 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. PubMed 19729114 ↗
  • 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. PubMed 20207271 ↗
  • 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. PubMed 26927298 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02169258
Lead sponsor
National Cheng-Kung University Hospital
Collaborators
Tainan Municipal Hospital, E-DA Hospital, Kaohsiung Medical University, National Taiwan University Hospital, Buddhist Tzu Chi General Hospital, Far Eastern Memorial Hospital, University of Alberta
Responsible party
Ting-Hsing Chao (Associate Professor and Attending Physician, National Cheng-Kung University Hospital) — Principal investigator
First posted
Jun 23, 2014
Start date
Jun 2014
Primary completion
Jun 2018 (estimated)
Completion
Dec 2018 (estimated)
Last update
Sep 25, 2015

Study contacts

Ting-Hsing Chao, MD
Contact
chaoth@mail.ncku.edu.tw
886-6-2353535 ext. 2382
Ting-Hsing Chao, MD
principal investigator · National Cheng-Kung University Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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