Total Occlusion of Coronary ArteryCTS-C-CTOPCINCT04549896
Computed Tomography Scan in Complex Chronic Total Occlusion Percutaneous Coronary Intervention;
A study testing CT scan and No CT scan in people with Total Occlusion of Coronary Artery, run by Elsan at 1 site in France.
Trial summary
The chronic total occlusion of a coronary artery is the most frequent cardiac disease in the developped countries. The percutaneous coronary intervention is one of the existing treatments. This procedure is long, expensive and uses a lot of contrast medium and X ray. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Total Occlusion of Coronary Artery
- What is being tested?
- CT scan and No CT scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 2022to Dec 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 years old and ≤ 90 years old,
- BMI ≤ 40 kg/m²,
- Dated and signed informed consent, before any study-related procedures
- Ability to understand and comply with the study procedures,
- Affiliate or recipient of a social security scheme,
- Coronary artery chronic total occlusion (TIMI 0 flow from > 3 months) associated with myocardial viability (intended like normokinetic/hypokinetic wall motion or instrumental data in favor of viability) associated with ≥ CCS2 angina or ≥ NHYA2 dyspnea or documented ischemia or ejection fraction <50%.
- Coronary angiography J-CTO score ≥ 2 (complex cases)
Who cannot join
- Pregnant or breastfeeding woman,
- Adults patients protected by law,
- Very frequent and irregular cardiac rhythm (>100/min.),
- More than one CTO to be treated by PCI,
- Coronary angiography J-CTO (Japan Chronic Total Occlusion) score 0/1
- Hemodynamic instability,
Show all 11Show fewer
- Anemia < 9g/dl,
- Gastrointestinal bleeding,
- Thrombocytopenia with < 50 000/mm3 platelets count,
- Severe valvular disease associated
- CT-Scan performed as part of the standard of care pathology diagnosis, before the inclusion
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Polyclinique Les Fleurs
Ollioules, 83190
Eugenio La Scala, MD, (0)4 94 06 98 82 ext. +33, epflascala@hotmail.com
Paul BARRAGAN, MD
About this study
Official title: Interest of Coronary CT Scan Before Complex Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI).
The chronic total occlusion of a coronary artery is the most frequent cardiac disease in the developped countries. The percutaneous coronary intervention is one of the existing treatments. This procedure is long, expensive and uses a lot of contrast medium and X ray. With this study, the investigators want to adress the impact of CT scan performed before the surgical procedure. A better knowledge of the patient's anatomy could lead to a better success rate of the operation, with a lower radiation, lower contrast injection, and a faster and more cost-efficient procedure.
Read the detailed description
A chronic total occlusion (CTO) is the complete obstruction of a coronary artery that has been established from more than 3 months with TIMI (Thrombolysis in Myocardial Infarction) 0 flow. This is a frequent pathology, demonstrated in 20% of patients studied with a coronary angiography. The patients affected by an isolated CTO or by a multi-vascular coronary disease with one or more CTO are an heterogenous population in relation to age, co-morbidity, risk factors.
The treatment of this disease is medical, interventional or surgical. The interventional option is often the first choice in case of symptoms or ischemia associated with viability of the myocardial wall, originally perfused by the occluded segment. Medical treatment is often not enough to reduce symptoms and to improve quality of life. Surgery is very invasive, especially for patients with mono-vascular disease, not always possible, especially in case of distal diffuse disease or heavy co-morbidity.
The Percutaneous Coronary Intervention (PCI) is a good option thanks to the improvement of materials and recanalization techniques (anterograde, retrograde and dissection re-entry). However, the procedure is often long, expensive, using a lot of contrast medium and X ray.
At the diagnosis stage of a CTO, the Japan Chronic Total Occlusion (J-CTO) score defines the complexity of the procedure : 0 easy, 1 intermediate, 2 hard, ≥ 3 very hard. The score is actually calculated with the angiography data after evaluation of the occlusion's proximal cap shape, presence of calcifications in the occluded segment, tortuosity of the occluded segment and length of the occlusion.
In addition to the angiography data, a CT scan of coronary artery can be performed as part of Standard of Care. In the study's coordinating center, more than 2000 CT scans are performed by the team of interventional cardiologists. Data generated from last generation CT scan are then interpreted to extrapolate informations about the occluded segment, the occluded artery and the contralateral artery.
CT scan is able to identify very well the calcium distribution in the occluded segment/artery, the true length of the occlusion, bends, collateral branches, distal vessel anatomy, coronary path and more, solving ambiguity of proximal cap and showing the shape of the distal cap. Thanks to this investigation, the investigators can better evaluate the J-CTO score and the CT Rector score. The CT Rector score is helping to grade the CTO difficulty before the PCI by predicting time-efficient guidewire crossing. The investigators can calculate the calcium score of the occluded artery to detect a critical value for the success of CTO PCI. The best strategy with appropriate material can then be chosen for the procedure PCI.
In this study, the investigators would like to demonstrate the interest in performing a CT scan as a part of the pathology diagnosis before the PCI in more complex occlusions (J-CTO score ≥ 2). The investigators think that the CT scan, with a last generation GE Revolution 256 slice machine, is actually the best method to evaluate the J-CTO score, the CT Rector score and to obtain other important information like anatomical position of the occluded artery and presence of side branches in the occluded segment.
A better evaluation of J-CTO score and complex anatomy will then allow the selection of the best technique for the procedure with probably a better success rate, lower radiation, lower contrast injection, and a faster and more cost-efficient procedure.
- Conditions
- Total Occlusion of Coronary Artery
- Being tested
- CT scan, No CT scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanProcedure or surgery
Surgeon will perform a CT scan before the surgery procedure (CTO PCI) in order to increase the success rate of the surgery.
No CT scanProcedure or surgery
The surgery procedure (CTO PCI) will be performed following the standard of care, meaning that the surgeon will not perform a CT scan before the surgery procedure.
| Study group | Role | What they receive |
|---|---|---|
| CT scan | Experimental | CT scan with a last generation 256 slice machine of occluded coronary artery before CTO PCI Receives: Procedure: CT scan |
| Control | Active comparator | No CT scan before CTO PCI Receives: Procedure: No CT scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with successful CTO PCI procedure in both groups
TIMI 3 flow restoration and residual stenosis < 30%, by wire crossing in less than (≤) 60 minutes guidewire manipulation. TIMI flow and residual stenosis will be evaluated by a pool of 2 cardiologists not involved in the procedure and blinded regarding the randomized group.
Measured: Immediately after surgery.
Secondary outcomes (20)
Total time of CTO PCI procedure
Duration of the surgery procedure given in minutes.
Measured: Immediately after surgery.
Rate of CTO PCI complications
Death, coronary perforation with cardiac tamponade requiring pericardiocentesis, myocardial infarction (if elevation of troponin/CK associated with change in electrocardiogram), stroke, major bleeding with lost of hemoglobin > 3g/dl.
Measured: 6 months starting from the date of the surgery.
Radiation level used during the CTO PCI procedure
Quantity of radiation used during the PCI (airKerma in Gy, DAP mGycm², fluoroscopy time in minutes).
Measured: Immediately after surgery.
Volume of iodine contrast medium used for the CTO PCI procedure
Quantity of iodine contrast medium used during the PCI (given in milliliters).
Measured: Immediately after surgery.
Cost of the the CTO PCI procedure
Total cost of the surgery procedure (given in euros).
Measured: Immediately after surgery.
Creatinine level before discharge
This endpoint summarizes the renal adverse events in both groups. A baseline creatinine level is always known before the coronary angiography that initializes the diagnostic and therapeutic pathway.
Measured: 24 hours after surgery
Safety assessed with Adverse Events reporting
Any adverse events will be reported (like contrast allergic reaction). Their relationship with the CT scan or PCI procedure will also be reported.
Measured: 6 months starting from the date of the surgery.
Angina and dyspnea
Symptoms (angina CCS class / dyspnea NYHA (New York Heart Association) class) will be collected at the CTO PCI visit and EOS visit.
Measured: 6 months starting from the date of the inclusion.
Major Adverse Cardiac Events
Major Adverse Cardiac Events (MACE: myocardial infarction, cardiovascular death, revascularization, stroke) will be collected at the CTO PCI visit and EOS visit.
Measured: 6 months starting the date of the inclusion.
renal failure collection
Renal failure will be collected at the CTO PCI visit and EOS visit.
Measured: 6 months starting the date of the inclusion.
Troponin measure
Levels of troponin will be reported.
Measured: Baseline.
CK measure
Levels of CK will be reported.
Measured: Baseline.
Creatinine measure
Levels of creatinine will be reported.
Measured: Baseline.
clearance of creatinine measure
Levels of the clearance of creatinine will be reported.
Measured: Baseline.
Hemoglobin measure
Levels of hemoglobin will be reported.
Measured: Baseline.
Troponin measure
Levels of troponin will be reported after the PCI at the CTO PCI visit.
Measured: 24 hours after surgery
CK measure
Levels of CK will be reported after the PCI at the CTO PCI visit.
Measured: 24 hours after surgery
Creatinine measure
Levels of creatinine will be reported after the PCI at the CTO PCI visit.
Measured: 24 hours after surgery
clearance of creatinine measure
Levels of the clearance of creatinine will be reported after the PCI at the CTO PCI visit.
Measured: 24 hours after surgery
Hemoglobin measure
Levels of hemoglobin will be reported after the PCI at the CTO PCI visit.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start1 Jun 2022
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Total Occlusion of Coronary ArteryStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Elsan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04549896
- Sponsor's protocol ID
- CTS-C-CTOPCI
- Acronym
- CTS-C-CTOPCI
- Status last verified
- Jun 2024
- First submitted
- 29 Jul 2020
- Last updated
- 26 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chesebro JH, Knatterud G, Roberts R, Borer J, Cohen LS, Dalen J, Dodge HT, Francis CK, Hillis D, Ludbrook P, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: A comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation. 1987 Jul;76(1):142-54. doi: 10.1161/01.cir.76.1.142.
PubMed 3109764Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.
PubMed 22402070Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, Ochiai M, Noguchi Y, Kato K, Shibata Y, Hiasa Y, Doi O, Yamashita T, Hinohara T, Tanaka H, Mitsudo K; J-CTO Registry Investigators. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv. 2011 Feb;4(2):213-21. doi: 10.1016/j.jcin.2010.09.024.
PubMed 21349461Rolf A, Werner GS, Schuhback A, Rixe J, Mollmann H, Nef HM, Gundermann C, Liebetrau C, Krombach GA, Hamm CW, Achenbach S. Preprocedural coronary CT angiography significantly improves success rates of PCI for chronic total occlusion. Int J Cardiovasc Imaging. 2013 Dec;29(8):1819-27. doi: 10.1007/s10554-013-0258-y. Epub 2013 Jun 23.
PubMed 23793727Yu CW, Lee HJ, Suh J, Lee NH, Park SM, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee SH, Choe YH, Kim SM, Choi JH. Coronary Computed Tomography Angiography Predicts Guidewire Crossing and Success of Percutaneous Intervention for Chronic Total Occlusion: Korean Multicenter CTO CT Registry Score as a Tool for Assessing Difficulty in Chronic Total Occlusion Percutaneous Coronary Intervention. Circ Cardiovasc Imaging. 2017 Apr;10(4):e005800. doi: 10.1161/CIRCIMAGING.116.005800.
PubMed 28389507Singh S, Singh N, Gulati GS, Ramakrishnan S, Kumar G, Sharma S, Bahl VK. Dual-Source Computed Tomography for Chronic Total Occlusion of Coronary Arteries. Catheter Cardiovasc Interv. 2016 Oct;88(4):E117-E125. doi: 10.1002/ccd.25516. Epub 2014 May 27.
PubMed 24740894Ghoshhajra BB, Takx RAP, Stone LL, Girard EE, Brilakis ES, Lombardi WL, Yeh RW, Jaffer FA. Real-time fusion of coronary CT angiography with x-ray fluoroscopy during chronic total occlusion PCI. Eur Radiol. 2017 Jun;27(6):2464-2473. doi: 10.1007/s00330-016-4599-5. Epub 2016 Sep 23.
PubMed 27663227Li Y, Xu N, Zhang J, Li M, Lu Z, Wei M, Lu B, Zhang Y. Procedural success of CTO recanalization: Comparison of the J-CTO score determined by coronary CT angiography to invasive angiography. J Cardiovasc Comput Tomogr. 2015 Nov-Dec;9(6):578-84. doi: 10.1016/j.jcct.2015.07.005. Epub 2015 Jul 23.
PubMed 26232276Opolski MP, Achenbach S. CT Angiography for Revascularization of CTO: Crossing the Borders of Diagnosis and Treatment. JACC Cardiovasc Imaging. 2015 Jul;8(7):846-58. doi: 10.1016/j.jcmg.2015.05.001.
PubMed 26183556Chen Y, Lu B, Hou ZH, Gao Y, Yu FF, Yin WH, Wang ZQ. Predicting successful percutaneous coronary intervention in patients with chronic total occlusion: the incremental value of a novel morphological parameter assessed by computed tomography. Int J Cardiovasc Imaging. 2015 Aug;31(6):1263-9. doi: 10.1007/s10554-015-0679-x. Epub 2015 May 17.
PubMed 25982175Opolski MP, Achenbach S, Schuhback A, Rolf A, Mollmann H, Nef H, Rixe J, Renker M, Witkowski A, Kepka C, Walther C, Schlundt C, Debski A, Jakubczyk M, Hamm CW. Coronary computed tomographic prediction rule for time-efficient guidewire crossing through chronic total occlusion: insights from the CT-RECTOR multicenter registry (Computed Tomography Registry of Chronic Total Occlusion Revascularization). JACC Cardiovasc Interv. 2015 Feb;8(2):257-267. doi: 10.1016/j.jcin.2014.07.031.
PubMed 25700748Takimura H, Muramatsu T, Tsukahara R. CT coronary angiography-guided percutaneous coronary intervention for chronic total occlusion combined with retrograde approach. J Invasive Cardiol. 2012 Jan;24(1):E5-9.
PubMed 22210595Rodriguez-Granillo GA, Rosales MA, Llaurado C, Ivanc TB, Rodriguez AE. Guidance of percutaneous coronary interventions by multidetector row computed tomography coronary angiography. EuroIntervention. 2011 Jan;6(6):773-8. doi: 10.4244/EIJV6I6A131.
PubMed 21205604Tajti P, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Mahmud E, Choi JW, Burke MN, Doing AH, Dattilo P, Toma C, Smith AJC, Uretsky B, Holper E, Wyman RM, Kandzari DE, Garcia S, Krestyaninov O, Khelimskii D, Koutouzis M, Tsiafoutis I, Moses JW, Lembo NJ, Parikh M, Kirtane AJ, Ali ZA, Doshi D, Rangan BV, Ungi I, Banerjee S, Brilakis ES. The Hybrid Approach to Chronic Total Occlusion Percutaneous Coronary Intervention: Update From the PROGRESS CTO Registry. JACC Cardiovasc Interv. 2018 Jul 23;11(14):1325-1335. doi: 10.1016/j.jcin.2018.02.036. Epub 2018 Apr 26.
PubMed 29706508Maeremans J, Walsh S, Knaapen P, Spratt JC, Avran A, Hanratty CG, Faurie B, Agostoni P, Bressollette E, Kayaert P, Bagnall AJ, Egred M, Smith D, Chase A, McEntegart MB, Smith WH, Harcombe A, Kelly P, Irving J, Smith EJ, Strange JW, Dens J. The Hybrid Algorithm for Treating Chronic Total Occlusions in Europe: The RECHARGE Registry. J Am Coll Cardiol. 2016 Nov 1;68(18):1958-1970. doi: 10.1016/j.jacc.2016.08.034.
PubMed 27788851
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Coronary CT Scan Before Complex Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI).
- ClinicalTrials.gov ID
- NCT04549896
- Acronym / sponsor ID
- CTS-C-CTOPCI / CTS-C-CTOPCI
- Conditions
- Total Occlusion of Coronary Artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- ElsanUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Sep 2020 (actual)
- 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 chronic total occlusion of a coronary artery is the most frequent cardiac disease in the developped countries. The percutaneous coronary intervention is one of the existing treatments. This procedure is long, expensive and uses a lot of contrast medium and X ray. With this study, the investigators want to adress the impact of CT scan performed before the surgical procedure. A better knowledge of the patient's anatomy could lead to a better success rate of the operation, with a lower radiation, lower contrast injection, and a faster and more cost-efficient procedure.
Detailed description
A chronic total occlusion (CTO) is the complete obstruction of a coronary artery that has been established from more than 3 months with TIMI (Thrombolysis in Myocardial Infarction) 0 flow. This is a frequent pathology, demonstrated in 20% of patients studied with a coronary angiography. The patients affected by an isolated CTO or by a multi-vascular coronary disease with one or more CTO are an heterogenous population in relation to age, co-morbidity, risk factors.
The treatment of this disease is medical, interventional or surgical. The interventional option is often the first choice in case of symptoms or ischemia associated with viability of the myocardial wall, originally perfused by the occluded segment. Medical treatment is often not enough to reduce symptoms and to improve quality of life. Surgery is very invasive, especially for patients with mono-vascular disease, not always possible, especially in case of distal diffuse disease or heavy co-morbidity.
The Percutaneous Coronary Intervention (PCI) is a good option thanks to the improvement of materials and recanalization techniques (anterograde, retrograde and dissection re-entry). However, the procedure is often long, expensive, using a lot of contrast medium and X ray.
At the diagnosis stage of a CTO, the Japan Chronic Total Occlusion (J-CTO) score defines the complexity of the procedure : 0 easy, 1 intermediate, 2 hard, ≥ 3 very hard. The score is actually calculated with the angiography data after evaluation of the occlusion's proximal cap shape, presence of calcifications in the occluded segment, tortuosity of the occluded segment and length of the occlusion.
In addition to the angiography data, a CT scan of coronary artery can be performed as part of Standard of Care. In the study's coordinating center, more than 2000 CT scans are performed by the team of interventional cardiologists. Data generated from last generation CT scan are then interpreted to extrapolate informations about the occluded segment, the occluded artery and the contralateral artery.
CT scan is able to identify very well the calcium distribution in the occluded segment/artery, the true length of the occlusion, bends, collateral branches, distal vessel anatomy, coronary path and more, solving ambiguity of proximal cap and showing the shape of the distal cap. Thanks to this investigation, the investigators can better evaluate the J-CTO score and the CT Rector score. The CT Rector score is helping to grade the CTO difficulty before the PCI by predicting time-efficient guidewire crossing. The investigators can calculate the calcium score of the occluded artery to detect a critical value for the success of CTO PCI. The best strategy with appropriate material can then be chosen for the procedure PCI.
In this study, the investigators would like to demonstrate the interest in performing a CT scan as a part of the pathology diagnosis before the PCI in more complex occlusions (J-CTO score ≥ 2). The investigators think that the CT scan, with a last generation GE Revolution 256 slice machine, is actually the best method to evaluate the J-CTO score, the CT Rector score and to obtain other important information like anatomical position of the occluded artery and presence of side branches in the occluded segment.
A better evaluation of J-CTO score and complex anatomy will then allow the selection of the best technique for the procedure with probably a better success rate, lower radiation, lower contrast injection, and a faster and more cost-efficient procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CT scan | Experimental | Procedure: CT scanCT scan with a last generation 256 slice machine of occluded coronary artery before CTO PCI |
| Control | Active comparator | Procedure: No CT scanNo CT scan before CTO PCI |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female ≥ 18 years old and ≤ 90 years old,
- BMI ≤ 40 kg/m²,
- Dated and signed informed consent, before any study-related procedures
- Ability to understand and comply with the study procedures,
- Affiliate or recipient of a social security scheme,
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding woman,
- Adults patients protected by law,
- Very frequent and irregular cardiac rhythm (>100/min.),
- More than one CTO to be treated by PCI,
- Coronary angiography J-CTO (Japan Chronic Total Occlusion) score 0/1
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 |
|---|---|---|
| CT scanSurgeon will perform a CT scan before the surgery procedure (CTO PCI) in order to increase the success rate of the surgery. | Procedure or surgery | CT scan |
| No CT scanThe surgery procedure (CTO PCI) will be performed following the standard of care, meaning that the surgeon will not perform a CT scan before the surgery procedure. | Procedure or surgery | Control |
Primary outcome
Number of patients with successful CTO PCI procedure in both groups
Time frame: Immediately after surgery.
TIMI 3 flow restoration and residual stenosis < 30%, by wire crossing in less than (≤) 60 minutes guidewire manipulation. TIMI flow and residual stenosis will be evaluated by a pool of 2 cardiologists not involved in the procedure and blinded regarding the randomized group.
20 secondary outcomes
Total time of CTO PCI procedure
Time frame: Immediately after surgery.
Rate of CTO PCI complications
Time frame: 6 months starting from the date of the surgery.
Radiation level used during the CTO PCI procedure
Time frame: Immediately after surgery.
Volume of iodine contrast medium used for the CTO PCI procedure
Time frame: Immediately after surgery.
Cost of the the CTO PCI procedure
Time frame: Immediately after surgery.
Creatinine level before discharge
Time frame: 24 hours after surgery
Safety assessed with Adverse Events reporting
Time frame: 6 months starting from the date of the surgery.
Angina and dyspnea
Time frame: 6 months starting from the date of the inclusion.
Major Adverse Cardiac Events
Time frame: 6 months starting the date of the inclusion.
renal failure collection
Time frame: 6 months starting the date of the inclusion.
Troponin measure
Time frame: Baseline.
CK measure
Time frame: Baseline.
Creatinine measure
Time frame: Baseline.
clearance of creatinine measure
Time frame: Baseline.
Hemoglobin measure
Time frame: Baseline.
Troponin measure
Time frame: 24 hours after surgery
CK measure
Time frame: 24 hours after surgery
Creatinine measure
Time frame: 24 hours after surgery
clearance of creatinine measure
Time frame: 24 hours after surgery
Hemoglobin measure
Time frame: 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2024.
- Background: PubMed 3109764Chesebro JH, Knatterud G, Roberts R, Borer J, Cohen LS, Dalen J, Dodge HT, Francis CK, Hillis D, Ludbrook P, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial, Phase I: A comparison between intravenous tissue plasminogen activator and intravenous streptokinase. Clinical findings through hospital discharge. Circulation. 1987 Jul;76(1):142-54. doi: 10.1161/01.cir.76.1.142.
- Background: PubMed 22402070Fefer P, Knudtson ML, Cheema AN, Galbraith PD, Osherov AB, Yalonetsky S, Gannot S, Samuel M, Weisbrod M, Bierstone D, Sparkes JD, Wright GA, Strauss BH. Current perspectives on coronary chronic total occlusions: the Canadian Multicenter Chronic Total Occlusions Registry. J Am Coll Cardiol. 2012 Mar 13;59(11):991-7. doi: 10.1016/j.jacc.2011.12.007.
- Background: PubMed 21349461Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, Ochiai M, Noguchi Y, Kato K, Shibata Y, Hiasa Y, Doi O, Yamashita T, Hinohara T, Tanaka H, Mitsudo K; J-CTO Registry Investigators. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes: the J-CTO (Multicenter CTO Registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv. 2011 Feb;4(2):213-21. doi: 10.1016/j.jcin.2010.09.024.
- Background: PubMed 23793727Rolf A, Werner GS, Schuhback A, Rixe J, Mollmann H, Nef HM, Gundermann C, Liebetrau C, Krombach GA, Hamm CW, Achenbach S. Preprocedural coronary CT angiography significantly improves success rates of PCI for chronic total occlusion. Int J Cardiovasc Imaging. 2013 Dec;29(8):1819-27. doi: 10.1007/s10554-013-0258-y. Epub 2013 Jun 23.
- Background: PubMed 28389507Yu CW, Lee HJ, Suh J, Lee NH, Park SM, Park TK, Yang JH, Song YB, Hahn JY, Choi SH, Gwon HC, Lee SH, Choe YH, Kim SM, Choi JH. Coronary Computed Tomography Angiography Predicts Guidewire Crossing and Success of Percutaneous Intervention for Chronic Total Occlusion: Korean Multicenter CTO CT Registry Score as a Tool for Assessing Difficulty in Chronic Total Occlusion Percutaneous Coronary Intervention. Circ Cardiovasc Imaging. 2017 Apr;10(4):e005800. doi: 10.1161/CIRCIMAGING.116.005800.
- Background: PubMed 24740894Singh S, Singh N, Gulati GS, Ramakrishnan S, Kumar G, Sharma S, Bahl VK. Dual-Source Computed Tomography for Chronic Total Occlusion of Coronary Arteries. Catheter Cardiovasc Interv. 2016 Oct;88(4):E117-E125. doi: 10.1002/ccd.25516. Epub 2014 May 27.
- Background: PubMed 27663227Ghoshhajra BB, Takx RAP, Stone LL, Girard EE, Brilakis ES, Lombardi WL, Yeh RW, Jaffer FA. Real-time fusion of coronary CT angiography with x-ray fluoroscopy during chronic total occlusion PCI. Eur Radiol. 2017 Jun;27(6):2464-2473. doi: 10.1007/s00330-016-4599-5. Epub 2016 Sep 23.
- Background: PubMed 26232276Li Y, Xu N, Zhang J, Li M, Lu Z, Wei M, Lu B, Zhang Y. Procedural success of CTO recanalization: Comparison of the J-CTO score determined by coronary CT angiography to invasive angiography. J Cardiovasc Comput Tomogr. 2015 Nov-Dec;9(6):578-84. doi: 10.1016/j.jcct.2015.07.005. Epub 2015 Jul 23.
- Background: PubMed 26183556Opolski MP, Achenbach S. CT Angiography for Revascularization of CTO: Crossing the Borders of Diagnosis and Treatment. JACC Cardiovasc Imaging. 2015 Jul;8(7):846-58. doi: 10.1016/j.jcmg.2015.05.001.
- Background: PubMed 25982175Chen Y, Lu B, Hou ZH, Gao Y, Yu FF, Yin WH, Wang ZQ. Predicting successful percutaneous coronary intervention in patients with chronic total occlusion: the incremental value of a novel morphological parameter assessed by computed tomography. Int J Cardiovasc Imaging. 2015 Aug;31(6):1263-9. doi: 10.1007/s10554-015-0679-x. Epub 2015 May 17.
- Background: PubMed 25700748Opolski MP, Achenbach S, Schuhback A, Rolf A, Mollmann H, Nef H, Rixe J, Renker M, Witkowski A, Kepka C, Walther C, Schlundt C, Debski A, Jakubczyk M, Hamm CW. Coronary computed tomographic prediction rule for time-efficient guidewire crossing through chronic total occlusion: insights from the CT-RECTOR multicenter registry (Computed Tomography Registry of Chronic Total Occlusion Revascularization). JACC Cardiovasc Interv. 2015 Feb;8(2):257-267. doi: 10.1016/j.jcin.2014.07.031.
- Background: PubMed 22210595Takimura H, Muramatsu T, Tsukahara R. CT coronary angiography-guided percutaneous coronary intervention for chronic total occlusion combined with retrograde approach. J Invasive Cardiol. 2012 Jan;24(1):E5-9.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT scan and No CT scan in people with Total Occlusion of Coronary Artery, run by Elsan at 1 site in France.
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 7 inclusion and 11 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 26 Jun 2024. 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 France. 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. 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 Eugenio LA SCALA, MD ((0)4 94 06 98 82 ext. +33, epflascala@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with successful CTO PCI procedure in both groups (time frame: Immediately after surgery.). 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 NCT04549896, which also lists 22 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 26 Jun 2024.