Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR

Coronary Artery Disease Clinical Trial

— PREDICT  

Official title:

Performance of a New REsting Pressure Index During Invasive Angiography Compared To Adenosine Hyperemic FFR

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03237169
• Other study ID #: 2017-02
• Status: Recruiting
• Start date: October 28, 2016
• Est. completion date: September 2018

Study information

• Verified date: May 2018
• Source: Centro Hospitalar Lisboa Ocidental
• Contact: Luis Raposo, MD
• Phone: +351962933777
• Email: lfor.md[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To test the feasibility and diagnostic accuracy of a new automated pressure derived resting index (Pd/Pamin), using FFR as gold standard, in de novo coronary lesions in which invasive physiological evaluation is warranted.

Description:

Coronary lesions with a potential indication for percutaneous coronary intervention or warranting invasive physiological interrogation (in the opinion of the investigator) will undergo PressureWire™ assessment under 2 conditions: rest and adenosine hyperemia. The measurements at rest (standard Pd/Pa and Pd/Pamin) will be repeated to assess test/retest repeatability. Subsequent treatment decisions will be made by the operator according to the standard practice based on the adenosine FFR value together with all other clinical information.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients undergoing FFR assessment for standard clinical indications, according to individual operator decision.

2. Age = 18 years.

3. Provided signed written informed consent for data collection the collection.

4. De novo coronary artery disease in target vessel.

5. Single or multiple vessel disease.

6. Patient eligible for elective or ad hoc PCI (or CABG), if revascularization is deemed indicated, in the setting of stable coronary artery disease or non-culprit lesions of non-ST elevation acute coronary syndromes (only in deferred procedures).

7. Stenosis deemed amenable for both evaluation with a pressure wire and for potential revascularization.

Exclusion Criteria:

1. Subjects with restenosis in the target vessel.

2. Known severe renal insufficiency (examples being but not limited to eGFR <30 ml/kg/min, serum creatinine = 2.5 mg/dL or on dialysis).

3. Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).

4. Vessel(s) and lesion(s) not amenable for evaluation with a PressureWire™ and/or revascularization.

5. Tandem lesions

6. Moderate lesions in patients with multivessel disease in whom at least one lesion in another major epicardic vessel is severe (to minimize lesion interaction), unless the severe lesion is treated first (see above).

7. Left ventricular ejection fraction <50%

8. Known severe left ventricular hypertrophy

9. Atrial fibrillation or any other significant arrhythmia (including an heart rate <50/min on sinus rhythm)

10. Systolic blood pressure <90 mmHg.

11. Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results

12. Currently participating in another clinical study that interferes with study results.

13. Pregnant or nursing females

14. Planned or prior heart transplantation or listed for heart transplant.

15. Any condition that precludes the subject from undergoing PCI or any of the protocol mandated procedures, for example subjects with a prior history heparin induced thrombocytopenia, known intolerance to adenosine or with a contra-indication for dual anti-platelet therapy.

16. Patients with severe valvular disease

17. Patients with severe pulmonary disease

18. Culprit lesions in ACS patients are not to be included nor non-culprit lesions in patients with a recent STEMI undergoing staged procedures.

19. Patients with a CTO, regardless of the presence and the extent of angiographic collaterals from the target vessel.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Fractional Flow Reserve, Myocardial
• Myocardial Ischemia

Locations

Country	Name	City	State
France	Department of Cardiology, University Hospital	Lille
Italy	Institute of Cardiology, Catholic University of the Sacred Heart	Rome
Portugal	Hospital Prof. Doutor Fernando da Fonseca	Amadora
Portugal	Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz	Carnaxide
Portugal	Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta	Lisboa
United States	St. Francis Hospital The Heart Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Centro Hospitalar Lisboa Ocidental	Abbott Vascular, Cardiovascular Research Foundation, New York

Countries where clinical trial is conducted

United States,  France,  Italy,  Portugal, 

References & Publications (8)

Berry C, van 't Veer M, Witt N, Kala P, Bocek O, Pyxaras SA, McClure JD, Fearon WF, Barbato E, Tonino PA, De Bruyne B, Pijls NH, Oldroyd KG. VERIFY (VERification of Instantaneous Wave-Free Ratio and Fractional Flow Reserve for the Assessment of Coronary Artery Stenosis Severity in EverydaY Practice): a multicenter study in consecutive patients. J Am Coll Cardiol. 2013 Apr 2;61(13):1421-7. doi: 10.1016/j.jacc.2012.09.065. Epub 2013 Feb 6. — View Citation

Ganz P, Abben R, Friedman PL, Garnic JD, Barry WH, Levin DC. Usefulness of transstenotic coronary pressure gradient measurements during diagnostic catheterization. Am J Cardiol. 1985 Apr 1;55(8):910-4. — View Citation

Ganz P, Harrington DP, Gaspar J, Barry WH. Phasic pressure gradients across coronary and renal artery stenoses in humans. Am Heart J. 1983 Dec;106(6):1399-406. — View Citation

Grüntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. N Engl J Med. 1979 Jul 12;301(2):61-8. — View Citation

Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines; Society for Cardiovascular Angiography and Interventions. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. J Am Coll Cardiol. 2011 Dec 6;58(24):e44-122. doi: 10.1016/j.jacc.2011.08.007. Epub 2011 Nov 7. — View Citation

Mamas MA, Horner S, Welch E, Ashworth A, Millington S, Fraser D, Fath-Ordoubadi F, Neyses L, El-Omar M. Resting Pd/Pa measured with intracoronary pressure wire strongly predicts fractional flow reserve. J Invasive Cardiol. 2010 Jun;22(6):260-5. — View Citation

Sen S, Escaned J, Malik IS, Mikhail GW, Foale RA, Mila R, Tarkin J, Petraco R, Broyd C, Jabbour R, Sethi A, Baker CS, Bellamy M, Al-Bustami M, Hackett D, Khan M, Lefroy D, Parker KH, Hughes AD, Francis DP, Di Mario C, Mayet J, Davies JE. Development and validation of a new adenosine-independent index of stenosis severity from coronary wave-intensity analysis: results of the ADVISE (ADenosine Vasodilator Independent Stenosis Evaluation) study. J Am Coll Cardiol. 2012 Apr 10;59(15):1392-402. doi: 10.1016/j.jacc.2011.11.003. Epub 2011 Dec 7. — View Citation

Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS); European Association for Percutaneous Cardiovascular Interventions (EAPCI), Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010 Oct;31(20):2501-55. doi: 10.1093/eurheartj/ehq277. Epub 2010 Aug 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of Pd/Pamin vs FFR	Agreement will be tested using the established FFR 0.8 threshold as the binary reference standard.	baseline
Secondary	Discriminative power of Pd/Pamin and the best cut-off, taking FFR as gold	ROC analysis using FFR as reference	baseline
Secondary	Feasibility of Pd/Pamin measurements	Description of how often can Pd/Pamin can be measured accurately	Baseline