Coronary Artery Disease Clinical Trial
— PULSEOfficial 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
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.
Status | Recruiting |
Enrollment | 550 |
Est. completion date | October 15, 2022 |
Est. primary completion date | December 15, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Azienda Ospedaliero-Universitaria di Ferrara | Ferrara | |
Italy | Ospedale San Luigi Gonzaga, Orbassano | Orbassano | |
Italy | AOU Città della Salute e della Scienza di Torino | Torino |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Città della Salute e della Scienza di Torino | Arcispedale Santa Maria Nuova-IRCCS, AUSL Romagna Rimini, Ospedale San Luigi Gonzaga, Orbassano, Ospedale Santa Croce-Carle Cuneo, Università degli Studi di Ferrara |
Italy,
Alfonso F, Byrne RA, Rivero F, Kastrati A. Current treatment of in-stent restenosis. J Am Coll Cardiol. 2014 Jun 24;63(24):2659-73. doi: 10.1016/j.jacc.2014.02.545. Epub 2014 Mar 13. Review. — View Citation
Authors/Task Force members, Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Sousa Uva M, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A. 2014 ESC/EACTS Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)Developed with the special contribution of the European Association of Percutaneous Cardiovascular Interventions (EAPCI). Eur Heart J. 2014 Oct 1;35(37):2541-619. doi: 10.1093/eurheartj/ehu278. Epub 2014 Aug 29. — View Citation
Biondi-Zoccai GG, Giraudi E, Moretti C, Sciuto F, Omedè P, Sillano D, Garrone P, Trevi GP, Sheiban I. Impact of routine angiographic follow-up after percutaneous coronary drug-eluting stenting for unprotected left main disease: the Turin Registry. Clin Res Cardiol. 2010 Apr;99(4):235-42. doi: 10.1007/s00392-009-0112-3. Epub 2010 Jan 3. — View Citation
Buchanan GL, Chieffo A, Bernelli C, Montorfano M, Carlino M, Latib A, Figini F, Giannini F, Durante A, Ielasi A, Castelli A, Colombo A. Two-year outcomes following unprotected left main stenting with first vs. new-generation drug-eluting stents: the FINE registry. EuroIntervention. 2013 Nov;9(7):809-16. doi: 10.4244/EIJV9I7A134. — View Citation
Cassese S, Byrne RA, Schulz S, Hoppman P, Kreutzer J, Feuchtenberger A, Ibrahim T, Ott I, Fusaro M, Schunkert H, Laugwitz KL, Kastrati A. Prognostic role of restenosis in 10 004 patients undergoing routine control angiography after coronary stenting. Eur Heart J. 2015 Jan 7;36(2):94-9. doi: 10.1093/eurheartj/ehu383. Epub 2014 Oct 8. — View Citation
D'Ascenzo F, Barbero U, Cerrato E, Lipinski MJ, Omedè P, Montefusco A, Taha S, Naganuma T, Reith S, Voros S, Latib A, Gonzalo N, Quadri G, Colombo A, Biondi-Zoccai G, Escaned J, Moretti C, Gaita F. Accuracy of intravascular ultrasound and optical coherence tomography in identifying functionally significant coronary stenosis according to vessel diameter: A meta-analysis of 2,581 patients and 2,807 lesions. Am Heart J. 2015 May;169(5):663-73. doi: 10.1016/j.ahj.2015.01.013. Epub 2015 Feb 21. — View Citation
D'Ascenzo F, Iannaccone M, Giordana F, Chieffo A, Connor SO, Napp LC, Chandran S, de la Torre Hernández JM, Chen SL, Varbella F, Omedè P, Taha S, Meliga E, Kawamoto H, Montefusco A, Chong M, Garot P, Sin L, Gasparetto V, Abdirashid M, Cerrato E, Biondi-Zoccai G, Gaita F, Escaned J, Hiddick Smith D, Lefèvre T, Colombo A, Sheiban I, Moretti C. Provisional vs. two-stent technique for unprotected left main coronary artery disease after ten years follow up: A propensity matched analysis. Int J Cardiol. 2016 May 15;211:37-42. doi: 10.1016/j.ijcard.2016.02.136. Epub 2016 Mar 3. — View Citation
Hicks KA, Tcheng JE, Bozkurt B, Chaitman BR, Cutlip DE, Farb A, Fonarow GC, Jacobs JP, Jaff MR, Lichtman JH, Limacher MC, Mahaffey KW, Mehran R, Nissen SE, Smith EE, Targum SL. 2014 ACC/AHA Key Data Elements and Definitions for Cardiovascular Endpoint Events in Clinical Trials: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Data Standards (Writing Committee to Develop Cardiovascular Endpoints Data Standards). J Am Coll Cardiol. 2015 Jul 28;66(4):403-69. doi: 10.1016/j.jacc.2014.12.018. Epub 2014 Dec 29. Erratum in: J Am Coll Cardiol. 2015 Aug 25;66(8):982. — View Citation
Lee JY, Park DW, Kim YH, Yun SC, Kim WJ, Kang SJ, Lee SW, Lee CW, Park SW, Park SJ. Incidence, predictors, treatment, and long-term prognosis of patients with restenosis after drug-eluting stent implantation for unprotected left main coronary artery disease. J Am Coll Cardiol. 2011 Mar 22;57(12):1349-58. doi: 10.1016/j.jacc.2010.10.041. — View Citation
Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999 Nov 2;100(18):1872-8. — View Citation
Mehran R, Rao SV, Bhatt DL, Gibson CM, Caixeta A, Eikelboom J, Kaul S, Wiviott SD, Menon V, Nikolsky E, Serebruany V, Valgimigli M, Vranckx P, Taggart D, Sabik JF, Cutlip DE, Krucoff MW, Ohman EM, Steg PG, White H. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011 Jun 14;123(23):2736-47. doi: 10.1161/CIRCULATIONAHA.110.009449. — View Citation
Mehta RL, Kellum JA, Shah SV, Molitoris BA, Ronco C, Warnock DG, Levin A; Acute Kidney Injury Network. Acute Kidney Injury Network: report of an initiative to improve outcomes in acute kidney injury. Crit Care. 2007;11(2):R31. — View Citation
Roura G, Gomez-Lara J, Ferreiro JL, Gomez-Hospital JA, Romaguera R, Teruel LM, Carreño E, Esplugas E, Alfonso F, Cequier A. Multislice CT for assessing in-stent dimensions after left main coronary artery stenting: a comparison with three dimensional intravascular ultrasound. Heart. 2013 Aug;99(15):1106-12. doi: 10.1136/heartjnl-2013-303679. Epub 2013 May 30. — View Citation
Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Ståhle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18. Erratum in: N Engl J Med. 2013 Feb 7;368(6):584. — View Citation
Sheiban I, Moretti C, D'Ascenzo F, Chieffo A, Taha S, Connor SO, Chandran S, de la Torre Hernández JM, Chen S, Varbella F, Omedè P, Iannaccone M, Meliga E, Kawamoto H, Montefusco A, Mervyn C, Garot P, Sin L, Gasparetto V, Abdirashid M, Cerrato E, Biondi Zoccai G, Gaita F, Escaned J, Hiddick Smith D, Lefèvre T, Colombo A. Long-Term (=10 Years) Safety of Percutaneous Treatment of Unprotected Left Main Stenosis With Drug-Eluting Stents. Am J Cardiol. 2016 Jul 1;118(1):32-9. doi: 10.1016/j.amjcard.2016.04.007. Epub 2016 Apr 26. — View Citation
Stone GW, Parise H, Witzenbichler B, Kirtane A, Guagliumi G, Peruga JZ, Brodie BR, Dudek D, Möckel M, Lansky AJ, Mehran R. Selection criteria for drug-eluting versus bare-metal stents and the impact of routine angiographic follow-up: 2-year insights from the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2010 Nov 2;56(19):1597-604. doi: 10.1016/j.jacc.2010.08.608. Epub 2010 Oct 1. — View Citation
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. — View Citation
Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, van' t Veer M, Klauss V, Manoharan G, Engstrøm T, Oldroyd KG, Ver Lee PN, MacCarthy PA, Fearon WF; FAME Study Investigators. Fractional flow reserve versus angiography for guiding percutaneous coronary intervention. N Engl J Med. 2009 Jan 15;360(3):213-24. doi: 10.1056/NEJMoa0807611. — View Citation
Uchida T, Popma J, Stone GW, Ellis SG, Turco MA, Ormiston JA, Muramatsu T, Nakamura M, Nanto S, Yokoi H, Baim DS. The clinical impact of routine angiographic follow-up in randomized trials of drug-eluting stents: a critical assessment of "oculostenotic" reintervention in patients with intermediate lesions. JACC Cardiovasc Interv. 2010 Apr;3(4):403-11. doi: 10.1016/j.jcin.2010.01.010. — View Citation
Valgimigli M, Chieffo A, Lefèvre T, Colombo A, Morice MC, Serruys PW. Revisiting the incidence and temporal distribution of cardiac and sudden death in patients undergoing elective intervention for unprotected left main coronary artery stenosis in the drug eluting stent era. EuroIntervention. 2007 Feb;2(4):435-43. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | AKI | Acute kidney injury (AKI) following CCT will constitute safety end-point | 2 days after CCT in the experimental arm | |
Other | Renal function impairment | reduction of glomerular filtration rate of >24% or end-stage chronic kidney disease | 18 months after the index revascularization | |
Other | Overall bleedings | Any bleeding regardless of severity, defined according to Bleeding Academic Research Consortium (BARC) criteria | 18 months after the index revascularization | |
Other | Major bleedings | BARC bleedings type III-IV-V | 18 months after the index revascularization | |
Other | procedural complications | Procedural complications following each percutaneous coronary intervention (PCI): periprocedural MI defined, arterial access site complications, acute kidney injury | Index hospitalization | |
Primary | Major adverse cardiovascular events (MACE) | composite and mutual exclusive end point including death, cardiovascular death, myocardial infarction (MI) (excluding periprocedural MI), unstable angina (UA), stent thrombosis | 18 months after the index revascularization | |
Secondary | Target lesion revascularization (TLR) | target lesion revascularization including any TLR, any unplanned TLR and TLR driven by PAC | 18 months after the index revascularization | |
Secondary | All cause death | death from any cause occurring during follow up | within 18 months from the index revascularization | |
Secondary | stent thrombosis | Any stent thrombosis (definite, probable or possible) | within 18 months from the index revascularization | |
Secondary | CV death | death from cardiovascular causes | within 18 months from the index revascularization | |
Secondary | Myocardial infarction | Myocardial infarction defined as non ST elevation acute coronary syndrome (NST-ACS) or ST elevation myocardial infarction (STEMI) | within 18 months from the index revascularization |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |