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

NCT03237169 | Unknown

• 1 other identifier: 2017-02
• Study Type: observational
• Target: 100
• Locations: 4 countries
• Sites: 6

Brief 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.

Conditions

Fractional Flow Reserve, Myocardial; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Discriminative power of Pd/Pamin and the best cut-off, taking FFR as gold

  baseline

• Feasibility of Pd/Pamin measurements

  Baseline

Study Arms (1)

Prospective cohort

Prospective cohort of patients with stable or stabilized coronary artery disease and de novo coronary lesions, in whom functional evaluation is performed, according do standard clinical indications.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive subjects scheduled for coronary angiography or PCI in whom operator decides to perform FFR will be approached for enrollment. Being a first-in-man study of a novel pressure index intended for future validation and use in a clinical setting, a full assessment of its range throughout the entire spectrum of lesion severity is warranted. As such, the protocol will allow for the inclusion of both less severe as well as of critical (\>90%) lesions. Patients with either single or multiple vessel disease will be included. Data on additional lesions may or may not be collected but will not be used in the study. Vessels with sequential stenosis and tandem lesions will be evaluated and treated according to routine clinical practice, but not included in the study data collected.

You may qualify if:

• Patients undergoing FFR assessment for standard clinical indications, according to individual operator decision.
• Age ≥ 18 years.
• Provided signed written informed consent for data collection the collection.
• De novo coronary artery disease in target vessel.
• Single or multiple vessel disease.
• 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).
• Stenosis deemed amenable for both evaluation with a pressure wire and for potential revascularization.

You may not qualify if:

• Subjects with restenosis in the target vessel.
• Known severe renal insufficiency (examples being but not limited to eGFR \<30 ml/kg/min, serum creatinine ≥ 2.5 mg/dL or on dialysis).
• Aorto-ostial lesion location within 3 mm of the aorta junction (both right and left).
• Vessel(s) and lesion(s) not amenable for evaluation with a PressureWire™ and/or revascularization.
• Tandem lesions
• 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).
• Left ventricular ejection fraction \<50%
• Known severe left ventricular hypertrophy
• Atrial fibrillation or any other significant arrhythmia (including an heart rate \<50/min on sinus rhythm)
• Systolic blood pressure \<90 mmHg.
• Any other medical condition that in the opinion of the investigator will interfere with patient safety or study results
• Currently participating in another clinical study that interferes with study results.
• Pregnant or nursing females
• Planned or prior heart transplantation or listed for heart transplant.
• 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.

Sponsors & Collaborators

• Centro Hospitalar Lisboa Ocidental: lead
• Abbott Medical Devices: collaborator
• Cardiovascular Research Foundation, New York: collaborator

Study Sites (6)

St. Francis Hospital The Heart Center

New York, New York, 11576, United States

RECRUITING

Department of Cardiology, University Hospital

Lille, France

RECRUITING

Institute of Cardiology, Catholic University of the Sacred Heart

Rome, Italy

RECRUITING

Hospital Prof. Doutor Fernando da Fonseca

Amadora, 2720-276, Portugal

RECRUITING

Centro Hospitalar de Lisboa Ocidental - Hospital de Santa Cruz

Carnaxide, 2790-134, Portugal

RECRUITING

Centro Hospitalar de Lisboa Central (CHLC) - Hospital de Santa Marta

Lisbon, Portugal

RECRUITING

Related Publications (8)

• 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. No abstract available.

  PMID: 22070834 BACKGROUND

• 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. No abstract available.

  PMID: 20802248 BACKGROUND

• 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.

  PMID: 20516504 BACKGROUND

• 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.

  PMID: 22154731 BACKGROUND

• 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. doi: 10.1016/0002-9149(85)90716-7.

  PMID: 3157307 BACKGROUND

• Gruntzig 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. doi: 10.1056/NEJM197907123010201.

  PMID: 449946 BACKGROUND

• 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.

  PMID: 23395076 BACKGROUND

• 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. doi: 10.1016/0002-8703(83)90052-2.

  PMID: 6650363 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Luis Raposo, MD

  Centro Hospitalar de Lisboa Ocidental

  PRINCIPAL INVESTIGATOR

• Sergio Bravo Baptista, MD, PhD

  Hospital Fernando da Fonseca

  STUDY CHAIR

Central Study Contacts

Luis Raposo, MD

CONTACT

+351962933777; lfor.md@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 2, 2017
• Study Start: October 28, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IT (1); FR (1); PT (3)