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

NCT02169258 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 700

Last updated 2015-09-25

No results posted yet for this 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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • Tainan Municipal Hospital

    collaborator OTHER

  • E-DA Hospital

    collaborator OTHER

  • Kaohsiung Medical University

    collaborator OTHER

  • National Taiwan University Hospital

    collaborator OTHER

  • Buddhist Tzu Chi General Hospital

    collaborator OTHER

  • Far Eastern Memorial Hospital

    collaborator OTHER

  • University of Alberta

    collaborator OTHER

  • National Cheng-Kung University Hospital

    lead OTHER

Principal Investigators

  • Ting-Hsing Chao, MD · National Cheng-Kung University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-06-30
Primary Completion
2018-06-30
Completion
2018-12-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02169258 on ClinicalTrials.gov