Prospective Global Registry for the Study of Chronic Total Occlusion Intervention

Coronary Artery Disease Clinical Trial

— PROGRESS-CTO  

Official title:

Multicenter Registry of Chronic Total Occlusion Interventions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02061436
• Other study ID #: #11-099
• Status: Recruiting
• Start date: January 2012
• Est. completion date: January 2024

Study information

• Verified date: March 2022
• Source: Minneapolis Heart Institute Foundation
• Contact: Emmanouil S Brilakis, MD, PhD
• Phone: (214) 857-1547
• Email: esbrilakis[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Percutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is increasingly being performed in patients with advanced coronary artery disease, but there is limited information on the techniques utilized and the procedural outcomes. The goal of this multicenter, investigator initiated registry is to collect information on treatment strategies and outcomes of consecutive patients undergoing CTO PCI among various participating centers. The information collected will be used to determine the frequency of CTO PCI performed at the participating sites and examine the procedural strategies utilized, and the procedural (both immediate and during follow-up) outcomes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: January 2024
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Patients undergoing CTO PCI at each of the participating centers.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Coronary Artery Disease

Locations

Country	Name	City	State
Canada	St. Boniface General Hospital	Winnipeg	Manitoba
Egypt	Aswan Heart Centre	Aswan
Greece	Henry Hunant Hospital Center	Athens
Greece	Korgialeneio-Benakeio Hellenic Red Cross General Hospital of Athens	Athens	Attica
Lebanon	St. George Hospital University Medical Center	Beirut
Russian Federation	Meshalkin Novosibirsk Research Institute	Novosibirsk	Novosibirsk Oblast
United States	Appleton Cardiology	Appleton	Wisconsin
United States	Emory University Hospital- Emory Heart and Vascular Center	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Peacehealth Cardiology	Bellingham	Washington
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Maimonides Medical Center	Brooklyn	New York
United States	Trinity Medical WNY	Buffalo	New York
United States	Northwestern Bluhm Cardiovascular Institute	Chicago	Illinois
United States	The Christ Hospital Ohio Heart & Vascular	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University Hospitals (UH) Case Western Reserve University	Cleveland	Ohio
United States	Baylor Heart and Vascular Hospital	Dallas	Texas
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	VA Dallas Medical Center	Dallas	Texas
United States	Henry Ford Medical Center	Detroit	Michigan
United States	Houston Methodist Hospital	Houston	Texas
United States	St. Vincent Heart Center	Indianapolis	Indiana
United States	Memorial Hospital	Jacksonville	Florida
United States	Mid America Heart Institute	Kansas City	Missouri
United States	Kettering Health Network	Kettering	Ohio
United States	Little Rock VA Medical Center	Little Rock	Arkansas
United States	Medical Center of the Rockies	Loveland	Colorado
United States	Wellstar Health System	Marietta	Georgia
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	Minneapolis VA Healthcare System and University of Minnesota	Minneapolis	Minnesota
United States	Tristar Centennial Medical Center	Nashville	Tennessee
United States	Carolina East Medical Center	New Bern	North Carolina
United States	Tulane University Heart and Vascular Institute	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	Oklahoma City VA Medical Center	Oklahoma City	Oklahoma
United States	Banner Samaritan Health Center	Phoenix	Arizona
United States	University of Pittsburgh Medical Center Presbyterian	Pittsburgh	Pennsylvania
United States	Baylor Scott & White Research Institute-The Heart Hospital Baylor Plano	Plano	Texas
United States	Baylor Scott and White Research Institute/ The Heart Hospital Baylor Plano	Plano	Texas
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Providence Heart & Vascular Institute	Portland	Oregon
United States	San Diego VAMC and University of California	San Diego	California
United States	Torrance Memorial Medical Center	Torrance	California
United States	Oklahoma Heart Institute at Hillcrest Medical Center	Tulsa	Oklahoma
United States	Providence Health Center	Waco	Texas
United States	WellSpan Heart & Vascular	York	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Minneapolis Heart Institute Foundation

Countries where clinical trial is conducted

United States,  Canada,  Egypt,  Greece,  Lebanon,  Russian Federation, 

References & Publications (25)

Alaswad K, Menon RV, Christopoulos G, Lombardi WL, Karmpaliotis D, Grantham JA, Marso SP, Wyman MR, Pokala NR, Patel SM, Kotsia AP, Rangan BV, Lembo N, Kandzari D, Lee J, Kalynych A, Carlson H, Garcia SA, Thompson CA, Banerjee S, Brilakis ES. Transradial — View Citation

Christakopoulos GE, Christopoulos G, Karmpaliotis D, Alaswad K, Yeh RW, Jaffer FA, Wyman MR, Lombardi WL, Tarar MN, Grantham JA, Kandzari DE, Lembo N, Moses JW, Kirtane AJ, Parikh M, Green P, Finn M, Garcia S, Doing AH, Hatem R, Thompson CA, Banerjee S, B — View Citation

Christakopoulos GE, Karmpaliotis D, Alaswad K, Yeh RW, Jaffer FA, Wyman RM, Lombardi W, Grantham JA, Kandzari DA, Lembo N, Moses JW, Kirtane A, Parikh M, Green P, Finn M, Garcia S, Doing A, Patel M, Bahadorani J, Christopoulos G, Karatasakis A, Thompson C — View Citation

Christopoulos G, Kandzari DE, Yeh RW, Jaffer FA, Karmpaliotis D, Wyman MR, Alaswad K, Lombardi W, Grantham JA, Moses J, Christakopoulos G, Tarar MNJ, Rangan BV, Lembo N, Garcia S, Cipher D, Thompson CA, Banerjee S, Brilakis ES. Development and Validation — View Citation

Christopoulos G, Karmpaliotis D, Alaswad K, Lombardi WL, Grantham JA, Rangan BV, Kotsia AP, Lembo N, Kandzari DE, Lee J, Kalynych A, Carlson H, Garcia S, Banerjee S, Thompson CA, Brilakis ES. The efficacy of "hybrid" percutaneous coronary intervention in — View Citation

Christopoulos G, Karmpaliotis D, Alaswad K, Yeh RW, Jaffer FA, Wyman RM, Lombardi WL, Menon RV, Grantham JA, Kandzari DE, Lembo N, Moses JW, Kirtane AJ, Parikh M, Green P, Finn M, Garcia S, Doing A, Patel M, Bahadorani J, Tarar MN, Christakopoulos GE, Tho — View Citation

Christopoulos G, Karmpaliotis D, Wyman MR, Alaswad K, McCabe J, Lombardi WL, Grantham JA, Marso SP, Kotsia AP, Rangan BV, Garcia SA, Lembo N, Kandzari D, Lee J, Kalynych A, Carlson H, Thompson CA, Banerjee S, Brilakis ES. Percutaneous intervention of circ — View Citation

Christopoulos G, Menon RV, Karmpaliotis D, Alaswad K, Lombardi W, Grantham A, Patel VG, Rangan BV, Kotsia AP, Lembo N, Kandzari D, Carlson H, Garcia S, Banerjee S, Thompson CA, Brilakis ES. The efficacy and safety of the "hybrid" approach to coronary chro — View Citation

Christopoulos G, Menon RV, Karmpaliotis D, Alaswad K, Lombardi W, Grantham JA, Michael TT, Patel VG, Rangan BV, Kotsia AP, Lembo N, Kandzari DE, Lee J, Kalynych A, Carlson H, Garcia S, Banerjee S, Thompson CA, Brilakis ES. Application of the "hybrid appro — View Citation

Christopoulos G, Wyman RM, Alaswad K, Karmpaliotis D, Lombardi W, Grantham JA, Yeh RW, Jaffer FA, Cipher DJ, Rangan BV, Christakopoulos GE, Kypreos MA, Lembo N, Kandzari D, Garcia S, Thompson CA, Banerjee S, Brilakis ES. Clinical Utility of the Japan-Chro — View Citation

Danek BA, Karatasakis A, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel MP, Bahadorani J, Lombardi WL, Wyman RM, Grantham JA, Kandzari DE, Lembo NJ, Doing AH, Toma C, Moses JW, Kirtane AJ, Ali ZA, Parikh M, Garcia S, Nguyen-Trong PK, Karacsonyi J, Al — View Citation

Danek BA, Karatasakis A, Karmpaliotis D, Alaswad K, Yeh RW, Jaffer FA, Patel M, Bahadorani J, Lombardi WL, Wyman MR, Grantham JA, Doing A, Moses JW, Kirtane A, Parikh M, Ali ZA, Kalra S, Kandzari DE, Lembo N, Garcia S, Rangan BV, Thompson CA, Banerjee S, — View Citation

Garcia S, Alraies MC, Karatasakis A, Yannopoulos D, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel MP, Bahadorani J, Karacsonyi J, Kalsaria P, Danek B, Banerjee S, Brilakis ES. Coronary artery spatial distribution of chronic total occlusions: Insight — View Citation

Karacsonyi J, Karatasakis A, Karmpaliotis D, Alaswad K, Yeh RW, Jaffer FA, Wyman MR, Lombardi WL, Grantham JA, Kandzari DE, Lembo N, Moses JW, Kirtane AJ, Parikh MA, Green P, Finn M, Garcia S, Doing A, Patel M, Bahadorani J, Martinez Parachini JR, Resende — View Citation

Karacsonyi J, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Bahadorani J, Doing A, Ali ZA, Karatasakis A, Danek BA, Rangan BV, Alame AJ, Banerjee S, Brilakis ES. Prevalence, indications and management of balloon uncrossable chronic total occlusio — View Citation

Karatasakis A, Danek BA, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Bahadorani JN, Lombardi WL, Wyman RM, Grantham JA, Kandzari DE, Lembo NJ, Doing AH, Toma C, Moses JW, Kirtane AJ, Parikh MA, Ali ZA, Garcia S, Kalsaria P, Karacsonyi J, Alame — View Citation

Karatasakis A, Danek BA, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel MP, Bahadorani JN, Wyman RM, Lombardi WL, Grantham JA, Kandzari DE, Lembo NJ, Doing AH, Moses JW, Kirtane AJ, Garcia S, Parikh MA, Ali ZA, Karacsonyi J, Kalra S, Rangan BV, Kalsa — View Citation

Karatasakis A, Iwnetu R, Danek BA, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Kandzari DE, Lembo NJ, Patel M, Mahmud E, Lombardi WL, Wyman RM, Grantham JA, Doing AH, Toma C, Choi JW, Uretsky BF, Moses JW, Kirtane AJ, Ali ZA, Parikh M, Karacsonyi J, Ran — View Citation

Karatasakis A, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel MP, Bahadorani JN, Lombardi WL, Wyman RM, Grantham JA, Kandzari DE, Lembo NJ, Doing AH, Toma C, Moses JW, Kirtane AJ, Ali Z, Parikh M, Garcia S, Danek BA, Karacsonyi J, Alame A, Kalsaria P — View Citation

Karatasakis A, Tarar MN, Karmpaliotis D, Alaswad K, Yeh RW, Jaffer FA, Wyman RM, Lombardi WL, Grantham JA, Kandzari DE, Lembo NJ, Moses JW, Kirtane AJ, Parikh M, Garcia S, Doing A, Pershad A, Shah A, Patel M, Bahadorani J, Shoultz CA Jr, Danek BA, Thompso — View Citation

Karmpaliotis D, Karatasakis A, Alaswad K, Jaffer FA, Yeh RW, Wyman RM, Lombardi WL, Grantham JA, Kandzari DE, Lembo NJ, Doing A, Patel M, Bahadorani JN, Moses JW, Kirtane AJ, Parikh M, Ali ZA, Kalra S, Nguyen-Trong PK, Danek BA, Karacsonyi J, Rangan BV, R — View Citation

Martinez-Parachini JR, Karatasakis A, Karmpaliotis D, Alaswad K, Jaffer FA, Yeh RW, Patel M, Bahadorani J, Doing A, Nguyen-Trong PK, Danek BA, Karacsonyi J, Alame A, Rangan BV, Thompson CA, Banerjee S, Brilakis ES. Impact of diabetes mellitus on acute out — View Citation

Nguyen-Trong PK, Alaswad K, Karmpaliotis D, Lombardi W, Grantham JA, Lembo N, Kandzari D, Karatasakis A, Karacsonyi J, Danek BA, Rangan BV, Roesle M, Ayers CR, Thompson CA, Banerjee S, Brilakis ES. Use of Saphenous Vein Bypass Grafts for Retrograde Recana — View Citation

Nguyen-Trong PK, Rangan BV, Karatasakis A, Danek BA, Christakopoulos GE, Martinez-Parachini JR, Resendes E, Ayers CR, Luna M, Abdullah S, Kumbhani DJ, Addo T, Grodin J, Banerjee S, Brilakis ES. Predictors and Outcomes of Side-Branch Occlusion in Coronary — View Citation

Sapontis J, Christopoulos G, Grantham JA, Wyman RM, Alaswad K, Karmpaliotis D, Lombardi WL, McCabe JM, Marso SP, Kotsia AP, Rangan BV, Christakopoulos GE, Garcia S, Thompson CA, Banerjee S, Brilakis ES. Procedural failure of chronic total occlusion percut — View Citation

* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	procedural success of chronic total occlusion PCI	Procedural success is defined as achievement of technical success with no in-hospital major adverse cardiac events (MACE). In-hospital MACE includes any of the following adverse events prior to hospital discharge: death from any cause, Q-wave myocardial infarction, urgent repeat target vessel revascularization with PCI or coronary bypass surgery, tamponade requiring pericardiocentesis or surgery, or stroke.	discharge from the hospital after PCI, which usually happens the day after the procedure
Secondary	technical success of chronic total occlusion PCI	Technical success of CTO PCI was defined as successful CTO revascularization with achievement of <30% residual diameter stenosis within the treated segment and restoration of TIMI grade 3 antegrade flow.	discharge from the hospital after PCI, which usually happens the day after the procedure
Secondary	major adverse cardiovascular events	In-hospital major adverse cardiovascular events (MACE) include any of the following adverse events prior to hospital discharge: death from any cause, Q-wave myocardial infarction, urgent repeat target vessel revascularization with PCI or coronary bypass surgery, tamponade requiring pericardiocentesis or surgery, or stroke.; MACE during clinical follow-up include death, myocardial infarction, target lesion and target vessel revascularization.	discharge from the hospital after PCI (which usually happens the day after the procedure) and during clinically-indicated follow-up. There are no pre-specified follow-up time periods - patients are assessed if and when they come to receive clinical care.

External Links

•   Official website of the Progress-CTO registry