Coronary Artery DiseaseNCT05100992
Progress Bifurcation Global Registry
An observational study of Coronary Artery Disease and Coronary Bifurcation Lesions, run by Minneapolis Heart Institute Foundation at 1 site in United States.
Trial summary
Coronary bifurcation lesions are lesions (or blockages) that occur at or near the intersection of a major coronary artery and one of the arteries' side branches. Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Coronary Bifurcation Lesions
- What is being tested?
- Percutaneous Coronary Interbention
- Type of treatment
- Surgery or procedure
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2020to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Adult, Older adult
Study population: Subjects over 18 years of age and undergoing bifurcation percutaneous coronary intervention at each of the participating center.
Who may be able to join
- Over 18 years of age
- undergoing bifurcation percutaneous coronary intervention
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, 55407
Bavana Rangan, BDS, MPH, 612-863-3852, bavana.rangan@allina.com
About this study
Official title: Prospective Global Registry of Percutaneous Coronary Intervention in Bifurcation Lesions (PROGRESS-BIFURCATION)
Coronary bifurcation lesions are lesions (or blockages) that occur at or near the intersection of a major coronary artery and one of the arteries' side branches.
Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized, and the procedural outcomes.
Read the detailed description
Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. Several techniques are currently being utilized to treat coronary bifurcation lesions, including a 1-stent provisional stenting technique. Various 2-stent techniques are also performed, including: double kiss crush (DK crush4), culotte, T and protrusion (TAP), crush, mini-crush, reverse crush and V-stenting. The optimal technique for bifurcation stenting when two stents are required remains controversial; however, the DK crush technique appears to have stronger data, especially for left main bifurcations. However, DK crush can be challenging to perform, requiring several steps and frequent troubleshooting.
The adoption of DK crush and other 2-stent bifurcation strategies, as well as the rigor of implementation, have received limited study. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized,
- Being tested
- Percutaneous Coronary Interbention
- Keywords
- bifurcation lesions, percutaneous coronary intervention
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Coronary InterbentionProcedure or surgery
Percutaneous Coronary Interbention
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success During Bifurcation PCI
procedural success is defined as the absence of in-hospital major cardiac adverse events (MACE), including any of the following adverse events prior to hospital discharge: death, stroke, myocardial infarction, recurrent angina requiring urgent repeat target vessel revascularization with PCI or coronary bypass surgery, and tamponade requiring pericardiocentesis or surgery.
Measured: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.
Secondary outcomes (1)
Technical Success
Technical success will be defined as successful bifurcation lesion recanalization by any method with achievement of < 30% residual stenosis and TIMI 3 flow in both the main vessel and side branch.
Measured: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start23 Apr 2020
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Minneapolis Heart Institute Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05100992
- Sponsor's protocol ID
- PROGRESS-BIFURCATION
- Status last verified
- Aug 2026
- First submitted
- 20 Sep 2021
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Strepkos D, Alexandrou M, Mutlu D, Carvalho PEP, Ser OS, Sara JDS, Krestyaninov O, Khelimskii D, Kultursay B, Karagoz A, Yildirim U, Soylu K, Uluganyan M, Mastrodemos O, Rangan BV, Jalli S, Voudris K, Burke MN, Sandoval Y, Brilakis ES. Bifurcation percutaneous coronary intervention in patients with prior coronary artery bypass graft surgery: Analysis from the PROGRESS-BIFURCATION registry. Cardiovasc Revasc Med. 2025 Dec;81:25-31. doi: 10.1016/j.carrev.2025.05.018. Epub 2025 May 17.
PubMed 40442003Strepkos D, Alexandrou M, Mutlu D, Carvalho PEP, Ser OS, Jalli S, Voudris K, Burke MN, Sandoval Y, Brilakis ES. Impact of Side Branch Occlusion on Patient Outcomes After Bifurcation Percutaneous Coronary Intervention. Catheter Cardiovasc Interv. 2025 Apr;105(5):1142-1148. doi: 10.1002/ccd.31439. Epub 2025 Feb 3.
PubMed 39898485Simsek B, Kostantinis S, Karacsonyi J, Allana S, Vemmou E, Nikolakopoulos I, Burke MN, Garcia S, Wang Y, Chavez I, Gossl M, Sorajja P, Mooney M, Poulose A, Sandoval Y, Traverse J, Rangan BV, Brilakis ES. Outcomes and challenges of the provisional stenting technique: Insights from the PROGRESS-BIFURCATION registry. Catheter Cardiovasc Interv. 2022 Nov;100(5):749-755. doi: 10.1002/ccd.30401. Epub 2022 Sep 19.
PubMed 36121014Simsek B, Kostantinis S, Karacsonyi J, Vemmou E, Nikolakopoulos I, Assali M, Burke MN, Garcia S, Wang Y, Chavez I, Goessl M, Sorajja P, Mooney M, Poulose A, Traverse J, Rangan BV, Brilakis ES. Challenges and outcomes of the double kissing crush stenting technique: Insights from the PROGRESS-BIFURCATION registry. Catheter Cardiovasc Interv. 2022 Mar;99(4):1038-1044. doi: 10.1002/ccd.30135. Epub 2022 Feb 23.
PubMed 35195331
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Global Registry of Percutaneous Coronary Intervention in Bifurcation Lesions (PROGRESS-BIFURCATION)
- ClinicalTrials.gov ID
- NCT05100992
- Acronym / sponsor ID
- PROGRESS-BIFURCATION
- Keywords
- bifurcation lesions, percutaneous coronary intervention
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Minneapolis Heart Institute FoundationUniversity, hospital or other
- Study start
- 23 Apr 2020 (actual)
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 29 Oct 2021 (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.
Coronary bifurcation lesions are lesions (or blockages) that occur at or near the intersection of a major coronary artery and one of the arteries' side branches.
Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized, and the procedural outcomes.
Detailed description
Numerous techniques and devices have been developed to treat coronary bifurcations; however, these types of lesions remain some of the most challenging, both in terms of procedural success and outcome. Several techniques are currently being utilized to treat coronary bifurcation lesions, including a 1-stent provisional stenting technique. Various 2-stent techniques are also performed, including: double kiss crush (DK crush4), culotte, T and protrusion (TAP), crush, mini-crush, reverse crush and V-stenting. The optimal technique for bifurcation stenting when two stents are required remains controversial; however, the DK crush technique appears to have stronger data, especially for left main bifurcations. However, DK crush can be challenging to perform, requiring several steps and frequent troubleshooting.
The adoption of DK crush and other 2-stent bifurcation strategies, as well as the rigor of implementation, have received limited study. This study is designed as an observational, multi-center registry that will collect information on treatment strategies and outcomes of consecutive patients undergoing percutaneous coronary interventions (PCI) in coronary bifurcations among various participating centers, in order to determine the frequency of bifurcation PCI, the procedural strategies utilized,
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects over 18 years of age and undergoing bifurcation percutaneous coronary intervention at each of the participating center.
Key inclusion criteria (2 listed)
- Over 18 years of age
- undergoing bifurcation percutaneous coronary intervention
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Percutaneous Coronary InterbentionPercutaneous Coronary Interbention | Procedure or surgery | – |
Primary outcome
Procedural Success During Bifurcation PCI
Time frame: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.
procedural success is defined as the absence of in-hospital major cardiac adverse events (MACE), including any of the following adverse events prior to hospital discharge: death, stroke, myocardial infarction, recurrent angina requiring urgent repeat target vessel revascularization with PCI or coronary bypass surgery, and tamponade requiring pericardiocentesis or surgery.
1 secondary outcome
Technical Success
Time frame: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
- Derived from this study: PubMed 40442003Strepkos D, Alexandrou M, Mutlu D, Carvalho PEP, Ser OS, Sara JDS, Krestyaninov O, Khelimskii D, Kultursay B, Karagoz A, Yildirim U, Soylu K, Uluganyan M, Mastrodemos O, Rangan BV, Jalli S, Voudris K, Burke MN, Sandoval Y, Brilakis ES. Bifurcation percutaneous coronary intervention in patients with prior coronary artery bypass graft surgery: Analysis from the PROGRESS-BIFURCATION registry. Cardiovasc Revasc Med. 2025 Dec;81:25-31. doi: 10.1016/j.carrev.2025.05.018. Epub 2025 May 17.
- Derived from this study: PubMed 39898485Strepkos D, Alexandrou M, Mutlu D, Carvalho PEP, Ser OS, Jalli S, Voudris K, Burke MN, Sandoval Y, Brilakis ES. Impact of Side Branch Occlusion on Patient Outcomes After Bifurcation Percutaneous Coronary Intervention. Catheter Cardiovasc Interv. 2025 Apr;105(5):1142-1148. doi: 10.1002/ccd.31439. Epub 2025 Feb 3.
- Derived from this study: PubMed 36121014Simsek B, Kostantinis S, Karacsonyi J, Allana S, Vemmou E, Nikolakopoulos I, Burke MN, Garcia S, Wang Y, Chavez I, Gossl M, Sorajja P, Mooney M, Poulose A, Sandoval Y, Traverse J, Rangan BV, Brilakis ES. Outcomes and challenges of the provisional stenting technique: Insights from the PROGRESS-BIFURCATION registry. Catheter Cardiovasc Interv. 2022 Nov;100(5):749-755. doi: 10.1002/ccd.30401. Epub 2022 Sep 19.
- Derived from this study: PubMed 35195331Simsek B, Kostantinis S, Karacsonyi J, Vemmou E, Nikolakopoulos I, Assali M, Burke MN, Garcia S, Wang Y, Chavez I, Goessl M, Sorajja P, Mooney M, Poulose A, Traverse J, Rangan BV, Brilakis ES. Challenges and outcomes of the double kissing crush stenting technique: Insights from the PROGRESS-BIFURCATION registry. Catheter Cardiovasc Interv. 2022 Mar;99(4):1038-1044. doi: 10.1002/ccd.30135. Epub 2022 Feb 23.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Coronary Bifurcation Lesions, run by Minneapolis Heart Institute Foundation at 1 site in United States.
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 2 inclusion and 0 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: looking for participants now, as of the sponsor's last update on 19 Aug 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emmanouil Brilakis, MD, PhD (612-863-3852, emmanouil.brilakis@allina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success During Bifurcation PCI (time frame: From Date of Procedure to Date of Hospital Discharge, approximately 48-72 hrs after index procedure.). 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 NCT05100992, which also lists 4 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 19 Aug 2026.