Study Summary
This trial is testing a new way to do a heart procedure on 150 people to see if it's safe and effective.
Eligible Conditions
- Coronary Artery Stenosis
- Coronary Artery Disease
- Coronary Restenosis
Treatment Effectiveness
Phase-Based Effectiveness
N/A
Study Objectives
1 Primary · 1 Secondary · Reporting Duration: 14 weeks
14 weeks
Staged Procedure Success
Vessel patency at time of staged stenting procedure
Trial Safety
Phase-Based Safety
Awards & Highlights
No Placebo Group
All patients enrolled in this trial will receive the new treatment.
Trial Design
0 Treatment Group
150 Total Participants · 0 Treatment Group
Primary Treatment: Treatment · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 14 weeks
Who is running the clinical trial?
Saint Luke's Health SystemLead Sponsor
40 Previous Clinical Trials
15,234 Total Patients Enrolled
Asahi-InteccUNKNOWN
Eligibility Criteria
Age 18+ · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:During a heart procedure, the operator attempted a technique called STAR, and you need further treatment in another procedure.
References
- Hirai, Taishi, J. Aaron Grantham, James Sapontis, David J. Cohen, Steven P. Marso, William Lombardi, Dimitri Karmpaliotis, et al.. 2017. “Impact of Subintimal Plaque Modification Procedures on Health Status After Unsuccessful Chronic Total Occlusion Angioplasty”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.27380.
- Goleski, Patrick J., Kenta Nakamura, Emily Liebeskind, Adam C. Salisbury, J. Aaron Grantham, James M. McCabe, and William L. Lombardi. 2018. “Revascularization of Coronary Chronic Total Occlusions with Subintimal Tracking and Reentry Followed by Deferred Stenting: Experience from a High‐volume Referral Center”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.27783.
- Sapontis, James, Adam C. Salisbury, Robert W. Yeh, David J. Cohen, Taishi Hirai, William Lombardi, James M. McCabe, et al.. 2017. “Early Procedural and Health Status Outcomes After Chronic Total Occlusion Angioplasty”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2017.05.065.
- Galassi, Alfredo Ruggero, Marouane Boukhris, Salvatore Davide Tomasello, Francesco Marzà, Salvatore Azzarelli, Simona Giubilato, and Hazem Khamis. 2014. “Long-term Clinical and Angiographic Outcomes of the Mini-star Technique as a Bailout Strategy for Percutaneous Coronary Intervention of Chronic Total Occlusion”. Canadian Journal of Cardiology. Elsevier BV. doi:10.1016/j.cjca.2014.07.016.
- Hirai, Taishi, J. Aaron Grantham, Kensey L. Gosch, Christian Patterson, Ajay J. Kirtane, William Lombardi, William J. Nicholson, Jeffrey Moses, Dimitri Karmpaliotis, and Adam C. Salisbury. 2020. “Impact of Subintimal or Plaque Modification on Repeat Chronic Total Occlusion Angioplasty Following an Unsuccessful Attempt”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2020.01.214.
- Brilakis, Emmanouil S., J. Aaron Grantham, Stéphane Rinfret, R. Michael Wyman, M. Nicholas Burke, Dimitri Karmpaliotis, Nicholas Lembo, et al.. 2012. “A Percutaneous Treatment Algorithm for Crossing Coronary Chronic Total Occlusions”. JACC: Cardiovascular Interventions. Elsevier BV. doi:10.1016/j.jcin.2012.02.006.
- Xenogiannis, Iosif, James W. Choi, Khaldoon Alaswad, Jaikirshan J. Khatri, Anthony H. Doing, Phil Dattilo, Farouc A. Jaffer, et al.. 2019. “Outcomes of Subintimal Plaque Modification in Chronic Total Occlusion Percutaneous Coronary Intervention”. Catheterization and Cardiovascular Interventions. Wiley. doi:10.1002/ccd.28614.
- Werner, Gerald S, Victoria Martin-Yuste, David Hildick-Smith, Nicolas Boudou, Georgios Sianos, Valery Gelev, Jose Ramon Rumoroso, et al.. 2018. “A Randomized Multicentre Trial to Compare Revascularization with Optimal Medical Therapy for the Treatment of Chronic Total Coronary Occlusions”. European Heart Journal. Oxford University Press (OUP). doi:10.1093/eurheartj/ehy220.
- Brilakis ES, Grantham JA, Rinfret S, Wyman RM, Burke MN, Karmpaliotis D, Lembo N, Pershad A, Kandzari DE, Buller CE, DeMartini T, Lombardi WL, Thompson CA. A percutaneous treatment algorithm for crossing coronary chronic total occlusions. JACC Cardiovasc Interv. 2012 Apr;5(4):367-79. doi: 10.1016/j.jcin.2012.02.006.
- Hirai T, Grantham JA, Gosch KL, Patterson C, Kirtane AJ, Lombardi W, Nicholson WJ, Moses J, Karmpaliotis D, Salisbury AC. Impact of Subintimal or Plaque Modification on Repeat Chronic Total Occlusion Angioplasty Following an Unsuccessful Attempt. JACC Cardiovasc Interv. 2020 Apr 27;13(8):1010-1012. doi: 10.1016/j.jcin.2020.01.214. No abstract available.
- Galassi AR, Boukhris M, Tomasello SD, Marza F, Azzarelli S, Giubilato S, Khamis H. Long-term clinical and angiographic outcomes of the mini-STAR technique as a bailout strategy for percutaneous coronary intervention of chronic total occlusion. Can J Cardiol. 2014 Nov;30(11):1400-6. doi: 10.1016/j.cjca.2014.07.016. Epub 2014 Jul 22.
- 2021. "STAR and Deferred Stenting Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05089864.
Frequently Asked Questions
What is the current number of participants recruited for this research?
"Confirmatively, clinicaltrials.gov lists this trial as actively recruiting patients. The study was initially posted on November 23rd 2021 and last updated December 21st of the same year; 150 people are sought from one centre." - Anonymous Online Contributor
Unverified Answer
Are researchers still accepting volunteers for this experiment?
"Affirmative. According to clinicaltrials.gov, this scientific experiment has been looking for participants since November 23rd 2021 and is still actively recruiting as of December 21st 2021. The trial aims to enlist 150 individuals from a single medical site." - Anonymous Online Contributor
Unverified Answer