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Angiographic Control vs. Ischemia-driven Management of Patients Treated With PCI on Left Main With Drug-eluting Stents (PULSE)

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ClinicalTrials.gov Identifier: NCT04144881
Recruitment Status : Recruiting
First Posted : October 30, 2019
Last Update Posted : November 4, 2019
Sponsor:
Collaborators:
Università degli Studi di Ferrara
Ospedale San Luigi Gonzaga, Orbassano
Ospedale Santa Croce-Carle Cuneo
Arcispedale Santa Maria Nuova-IRCCS
AUSL Romagna Rimini
Information provided by (Responsible Party):
Fabrizio D'Ascenzo, Azienda Ospedaliera Città della Salute e della Scienza di Torino

Brief Summary:
The present study aims to compare a planned angiographic control (PAC) follow-up strategy vs. conservative management for patients treated with drug-eluting stents on unprotected left main artery in a prospective, randomized setting. PAC will be performed by coronary computed tomography (CCT), to avoid the limitations of the invasive coronary angiography which is usually employed to perform PAC. The superiority of a PAC-based approach will be tested on a hard clinical end-point such as the incidence of major adverse cardiovascular events. The investigators will also assess the performance of CCT as a tool to perform PAC.

Condition or disease Intervention/treatment Phase
Acute Coronary Syndrome Stable Chronic Angina Coronary Artery Disease Left Main Coronary Artery Disease Diagnostic Test: coronary computed tomography Not Applicable

Detailed Description:

Given the undefined picture surrounding the appropriateness of planned angiographic control (PAC) following percutaneous coronary intervention (PCI) of the unprotected left main (ULM) with drug-eluting stents (DES), our aim is to evaluate, in a prospective, randomized, setting, the potential benefits of a PAC-based strategy vs. ischemia and symptoms driven conservative management. The disease of the native ULM is associated with an unfavorable prognostic outcome, which can be at least partially reversed by revascularization. Significant stenosis of the stented ULM caused by in-stent restenosis (ISR), however, presents some peculiar pathophysiological, flow-related and shear-stress features, which partly makes it a distinct disease as compared to native vessel atherosclerosis. Treatment of ISR, moreover, is a scarcely standardized and often complex procedure; some uncertainties still persist regarding the best strategy to treat ISR (stent-in-stent, drug-eluting balloons, dilation with conventional balloons). Computed coronary tomography (CCT) can precisely and not-invasively assess the presence of ISR in the stented ULM, without exposing the patients to the risks of invasive catheterization. CCT may provide an accurate reconstruction of the stented vessels, exposing the patients to a limited amount of contrast dye (approximately, 80-100 cc) and of radiation dose (approximately, 92 mGy). CCT has a very high negative predictive value for ISR, thus limiting the negative impact of the indiscriminate execution of invasive angiography on all patients treated by PCI of the ULM. Only patients with relevant ISR of ULM at CCT will undergo coronary angiography to confirm the presence of critical stenosis, and fractional flow reserve (FFR) and/or intravascular ultrasound (IVUS) will be performed in dubious cases.

An increased rate of PCI has to be taken in to account with a PAC-based approach. However, with the accurate, stepwise selection of the patients and the lesions amenable to PCI of our study protocol, based on CCT, coronary angiography and, where necessary, FFR/IVUS, the increased rate of PCI is not expected to bear a negative prognostic impact. Based on these premises, our hypothesis is that early, appropriate, detection of ULM ISR and its subsequent treatment may positively impact patients' survival and reduce the incidence of adverse cardiovascular events.

Specific aim 1:

Evaluation of the effectiveness and safety of a PAC-based approach to follow-up patients treated by PCI of the ULM with DES-II

Specific aim 2:

Assessment of the incidence of ISR in patients undergoing PCI of the ULM with DES-II and evaluation of the diagnostic accuracy of CCT in the evaluation of ISR in the stented ULM

Specific Aim 3:

Assessment of the prognostic implications and safety of the PCI of ISR of the ULM detected by PAC as compared to conservative management with revascularization driven by symptoms and ischemia.

For this purpose in this prospective, randomized controlled trial (RCT), patients will be enrolled following the index percutaneous revascularization of ULM with DES. Patients will be randomized in a 1:1 fashion to PAC-based management with CCT vs.

symptoms and ischemia driven conservative management.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 550 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Angiographic Control vs. Ischemia-driven Management of Patients Undergoing Percutaneous Revascularization of the Unprotected Left Main Coronary Artery With Second-generation Drug Eluting Stents: the PULSE Trial
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : December 15, 2020
Estimated Study Completion Date : October 15, 2022

Arm Intervention/treatment
Experimental: coronary computed tomography Diagnostic Test: coronary computed tomography
patients randomized in this arm will perform computed coronary tomography 6 months after the index percutaneous revascularization on unprotected left main artery

No Intervention: conservative (ischemia-guided) management



Primary Outcome Measures :
  1. Major adverse cardiovascular events (MACE) [ Time Frame: 18 months after the index revascularization ]
    composite and mutual exclusive end point including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina (UA), stent thrombosis


Secondary Outcome Measures :
  1. Target lesion revascularization (TLR) [ Time Frame: 18 months after the index revascularization ]
    target lesion revascularization including any TLR, any unplanned TLR and TLR driven by PAC

  2. All cause death [ Time Frame: within 18 months from the index revascularization ]
    death from any cause occurring during follow up

  3. stent thrombosis [ Time Frame: within 18 months from the index revascularization ]
    Any stent thrombosis (definite, probable or possible)

  4. CV death [ Time Frame: within 18 months from the index revascularization ]
    death from cardiovascular causes

  5. Myocardial infarction [ Time Frame: within 18 months from the index revascularization ]
    Myocardial infarction defined as non ST elevation acute coronary syndrome (NST-ACS) or ST elevation myocardial infarction (STEMI)


Other Outcome Measures:
  1. AKI [ Time Frame: 2 days after CCT in the experimental arm ]
    Acute kidney injury (AKI) following CCT will constitute safety end-point

  2. Renal function impairment [ Time Frame: 18 months after the index revascularization ]
    reduction of glomerular filtration rate of >24% or end-stage chronic kidney disease

  3. Overall bleedings [ Time Frame: 18 months after the index revascularization ]
    Any bleeding regardless of severity, defined according to Bleeding Academic Research Consortium (BARC) criteria

  4. Major bleedings [ Time Frame: 18 months after the index revascularization ]
    BARC bleedings type III-IV-V

  5. procedural complications [ Time Frame: Index hospitalization ]
    Procedural complications following each percutaneous coronary intervention (PCI): periprocedural MI defined, arterial access site complications, acute kidney injury



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients with ULM disease treated by PCI with DES-II with the following inclusion criteria:

  • Age 18-85.
  • Glomerular filtration rate > 30 ml/min Indication to percutaneous revascularization of ULM according to Syntax score (< 33) or, in dubious cases, after Heart Team evaluation

Exclusion Criteria:

  • Cardiogenic shock
  • Refusal or inability to provide informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144881


Contacts
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Contact: Fabrizio D'Ascenzo, MD +390116335942 fabrizio.dascenzo@gmail.com

Locations
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Italy
Azienda Ospedaliero-Universitaria di Ferrara Active, not recruiting
Ferrara, Italy, 44124
Ospedale San Luigi Gonzaga, Orbassano Active, not recruiting
Orbassano, Italy, 10043
AOU Città della Salute e della Scienza di Torino Recruiting
Torino, Italy, 10126
Contact: Fabrizio D'Ascenzo, MD    +390116336023    fabrizio.dascenzo@gmail.com   
Sponsors and Collaborators
Azienda Ospedaliera Città della Salute e della Scienza di Torino
Università degli Studi di Ferrara
Ospedale San Luigi Gonzaga, Orbassano
Ospedale Santa Croce-Carle Cuneo
Arcispedale Santa Maria Nuova-IRCCS
AUSL Romagna Rimini
Investigators
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Principal Investigator: Fabrizio D'Ascenzo, MD AOU Città della Salute e della Scienza di Torino
Publications:
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction, Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasché P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Fabrizio D'Ascenzo, Medical Doctor, Azienda Ospedaliera Città della Salute e della Scienza di Torino
ClinicalTrials.gov Identifier: NCT04144881    
Other Study ID Numbers: PULSE
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Acute Coronary Syndrome
Angina, Stable
Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes
Angina Pectoris
Chest Pain
Pain
Neurologic Manifestations