Peripheral Artery DiseasePIROUETTEPTANCT02169258
Routine Coronary Catheterization in Low Extremity Artery Disease Undergoing Percutaneous Transluminal Angioplasty
A study testing Systemic Strategy in people with Peripheral Artery Disease and Coronary Artery Disease, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Peripheral Artery Disease, Coronary Artery Disease
- What is being tested?
- Systemic Strategy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 1 siteTaiwan
- Study dates
- Jun 2014to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Known LEAD (documented by previous angiography or sonography performed by the operators) admitted for elective PTA
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan, 704
Ting-Hsing Chao, MD, 886-6-2353535 ext. 2382, chaoth@mail.ncku.edu.tw
Cheng-Han Lee, MD/PhD
About this study
Official title: 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.
Read the 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
- 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
- Conditions
- Peripheral Artery Disease, Coronary Artery Disease
- Being tested
- Systemic Strategy
- Keywords
- coronary artery disease, peripheral artery disease, percutaneous transluminal angioplasty, coronary angiography, revascularization, gene polymorphisms, microRNAs
- Medical subject headings
- Peripheral Arterial Disease, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic StrategyProcedure or surgery
Also called Routine Coronary Angiography before PTA
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.
| Study group | Role | What they receive |
|---|---|---|
| Selective Strategy | Placebo comparator | non-invasive evaluation of possible myocardial ischemia by using DSE or dTS followed by coronary angiography if the test is positive for ischemia Receives: Procedure: Systemic Strategy |
| Registry | No intervention | Clinical decisions are reached by consensus of operators, patients and family as usual care |
| Systemic Strategy | Active comparator | Routine coronary angiography before PTA without a previous non-invasive stress test Receives: Procedure: Systemic Strategy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Composite of Major Adverse Cardiac Event (MACE)
cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization
Measured: up to 48 months
Secondary outcomes (2)
MACE between the Screening and 30 days after PTA
cardiovascular death, nonfatal myocardial infarction, nonfatal stroke, and any unplanned coronary revascularization
Measured: 30 days after indexed PTA
Time to Composite of major coronary events
fatal or nonfatal myocardial infarction, recurrent angina pectoris, and any unplanned coronary revascularization
Measured: Up to 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionJun 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- 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
- Principal investigator, Ting-Hsing Chao, National Cheng-Kung University Hospital
- Investigators
- Ting-Hsing Chao, MD, Principal investigator, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02169258
- Sponsor's protocol ID
- B-BR-103-023
- Acronym
- PIROUETTEPTA
- Status last verified
- Sep 2015
- First submitted
- 19 Jun 2014
- Last updated
- 25 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
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 24357434Monaco 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 19729114Duran 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 20207271Chen 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
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of ROUtine Coronary CathETerization in Low Extremity ArTEry Disease Undergoing Percutaneous Transluminal Angioplasty (PIROUETTE-PTA Study)
- ClinicalTrials.gov ID
- NCT02169258
- Acronym / sponsor ID
- PIROUETTEPTA / B-BR-103-023
- Conditions
- Peripheral Artery Disease, Coronary Artery Disease
- Keywords
- coronary artery disease, peripheral artery disease, percutaneous transluminal angioplasty, coronary angiography, revascularization, gene polymorphisms, microRNAs
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- 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
- Study start
- Jun 2014
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Selective Strategy | Placebo comparator | Procedure: Systemic Strategynon-invasive evaluation of possible myocardial ischemia by using DSE or dTS followed by coronary angiography if the test is positive for ischemia |
| Registry | No intervention | –Clinical decisions are reached by consensus of operators, patients and family as usual care |
| Systemic Strategy | Active comparator | Procedure: Systemic StrategyRoutine coronary angiography before PTA without a previous non-invasive stress test |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Known LEAD (documented by previous angiography or sonography performed by the operators) admitted for elective PTA
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic StrategyAlso: Routine Coronary Angiography before PTASignificant 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. | Procedure or surgery | Selective Strategy, Systemic Strategy |
Primary outcome
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
2 secondary outcomes
MACE between the Screening and 30 days after PTA
Time frame: 30 days after indexed PTA
Time to Composite of major coronary events
Time frame: Up to 48 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2015.
- Background: PubMed 24357434Chang 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.
- Background: PubMed 19729114Monaco 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.
- Background: PubMed 20207271Duran 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.
- Derived from this study: PubMed 26927298Chen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ting-Hsing Chao, MD principal investigator
National Cheng-Kung University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systemic Strategy in people with Peripheral Artery Disease and Coronary Artery Disease, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting-Hsing Chao, MD (886-6-2353535 ext. 2382, chaoth@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Composite of Major Adverse Cardiac Event (MACE) (time frame: up to 48 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02169258, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2015.