Chronic Coronary OcclusionNCT03265769
Femoral or Radial Approach in Coronary Chronic Total Occlusion
A study testing radial access site and femoral access site in people with Chronic Coronary Occlusion, run by Acibadem University at 4 sites in Turkey (Türkiye).
Trial summary
Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly performed using bilateral transfemoral access and 8 French guiding catheters. However, transfemoral approach (TFA) is associated with higher risk of vascular access complications.5 It has been reported that using transradial… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Coronary Occlusion
- What is being tested?
- radial access site and femoral access site
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 610 participants
- Where
- 4 sitesTurkey (Türkiye)
- Study dates
- 8 Aug 2017to 8 Jul 2021
- 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
- Any patient with coronary total occlusion >3 months and indication for intervention
Who cannot join
- Acute coronary syndrome within 3 months
Trial locations and contacts
4 sites in 1 country.
Turkey (Türkiye)4 sites
Acibadem University
Istanbul
Haseki Cradiology Institute
Istanbul
Memorial Hospital
Istanbul
Erciyes University
Kayseri
About this study
Official title: Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial (FORT CTO TRIAL)
Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly performed using bilateral transfemoral access and 8 French guiding catheters. However, transfemoral approach (TFA) is associated with higher risk of vascular access complications.5 It has been reported that using transradial approach (TRA) reduces vascular complications and may be associated with a better clinical outcome. Transradial access is also used in complex PCI interventions.There is a growing body of evidence regarding the use of this approach also in CTO procedures. In available literature, all studies comparing TRA vs. TFA in CTO consisted of single center and single operator experience. Besides, none of them is randomized. To fill in the gap, we sought to examine the technique and outcomes of transradial vs. transfemoral CTO PCI in a contemporary multicenter randomized study.
Read the detailed description
All consecutive patients referred for CTO PCI between August 2017 and July 2021 at Acibadem University Kocaeli Acibadem Hospital, Kocaeli; Erciyes University Medical Faculty, Kayseri; Istanbul University Cerrahpasa Medical Faculty, Haseki Cardiology Institute; Istanbul; Memorial Bahcelievler Hospital, Istanbul were screened for enrollment in the study. The exclusion criteria included: (a) any acute coronary syndrome within 3 months; (b) severe heart failure issues; (c)severe renal failure (d) failure to provide written informed consent.The radial access group consisted of patients with single or bi-radial approach. Any femoral artery puncture was considered a femoral case. For example, a crossover from any radial to femoral access was considered a femoral case. Procedures were performed by 4 interventional cardiologists, who are dedicated radial operators, at 4 different centers. The protocol was approved by the institutional review board and all patients provided written informed consent.
- Conditions
- Chronic Coronary Occlusion
- Being tested
- radial access site, femoral access site
- Keywords
- Femoral approach, Radial approach, Chronic total occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radial access siteOther
radial route
femoral access siteOther
femoral route
| Study group | Role | What they receive |
|---|---|---|
| Transradial approach | Active comparator | target vessel revascularization via radial access site is labeled as transradial approach Receives: Other: radial access site |
| Transfemoral approach | Active comparator | target vessel revascularization via femoral access site is labeled as transfemoral approach Receives: Other: femoral access site |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural success
Technical success without any in-hospital event
Measured: 24 hours
Secondary outcomes (1)
Major access site complications
Major bleeding, vascular complication requiring intervention and hematomas ≥ 10 cm
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start8 Aug 2017
- Primary completion8 Jul 2021
- Study completion8 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Coronary OcclusionStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- None (open label)
- Enrolment
- 610 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sevket Gorgulu, MD, Study chair, Acibadem University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03265769
- Sponsor's protocol ID
- Atadek2017/13
- Status last verified
- Sep 2021
- First submitted
- 27 Aug 2017
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gorgulu S, Kalay N, Norgaz T, Kocas C, Goktekin O, Brilakis ES. Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial. JACC Cardiovasc Interv. 2022 Apr 25;15(8):823-830. doi: 10.1016/j.jcin.2022.02.012.
PubMed 35450683
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Femoral or Radial Approach in the Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial (FORT CTO TRIAL)
- ClinicalTrials.gov ID
- NCT03265769
- Acronym / sponsor ID
- Atadek2017/13
- Conditions
- Chronic Coronary Occlusion
- Keywords
- Femoral approach, Radial approach, Chronic total occlusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 610 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- 8 Aug 2017 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 8 Jul 2021 (actual)
- First posted
- 29 Aug 2017 (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.
Pecutaneous coronary intervention (PCI) of chronic total occlusions (CTOs) is most commonly performed using bilateral transfemoral access and 8 French guiding catheters. However, transfemoral approach (TFA) is associated with higher risk of vascular access complications.5 It has been reported that using transradial approach (TRA) reduces vascular complications and may be associated with a better clinical outcome. Transradial access is also used in complex PCI interventions.There is a growing body of evidence regarding the use of this approach also in CTO procedures. In available literature, all studies comparing TRA vs. TFA in CTO consisted of single center and single operator experience. Besides, none of them is randomized. To fill in the gap, we sought to examine the technique and outcomes of transradial vs. transfemoral CTO PCI in a contemporary multicenter randomized study.
Detailed description
All consecutive patients referred for CTO PCI between August 2017 and July 2021 at Acibadem University Kocaeli Acibadem Hospital, Kocaeli; Erciyes University Medical Faculty, Kayseri; Istanbul University Cerrahpasa Medical Faculty, Haseki Cardiology Institute; Istanbul; Memorial Bahcelievler Hospital, Istanbul were screened for enrollment in the study. The exclusion criteria included: (a) any acute coronary syndrome within 3 months; (b) severe heart failure issues; (c)severe renal failure (d) failure to provide written informed consent.The radial access group consisted of patients with single or bi-radial approach. Any femoral artery puncture was considered a femoral case. For example, a crossover from any radial to femoral access was considered a femoral case. Procedures were performed by 4 interventional cardiologists, who are dedicated radial operators, at 4 different centers. The protocol was approved by the institutional review board and all patients provided written informed consent.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transradial approach | Active comparator | Other: radial access sitetarget vessel revascularization via radial access site is labeled as transradial approach |
| Transfemoral approach | Active comparator | Other: femoral access sitetarget vessel revascularization via femoral access site is labeled as transfemoral approach |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient with coronary total occlusion >3 months and indication for intervention
Key exclusion criteria (1 listed)
- Acute coronary syndrome within 3 months
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 |
|---|---|---|
| radial access siteradial route | Other | Transradial approach |
| femoral access sitefemoral route | Other | Transfemoral approach |
Primary outcome
Procedural success
Time frame: 24 hours
Technical success without any in-hospital event
1 secondary outcome
Major access site complications
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Derived from this study: PubMed 35450683Gorgulu S, Kalay N, Norgaz T, Kocas C, Goktekin O, Brilakis ES. Femoral or Radial Approach in Treatment of Coronary Chronic Total Occlusion: A Randomized Clinical Trial. JACC Cardiovasc Interv. 2022 Apr 25;15(8):823-830. doi: 10.1016/j.jcin.2022.02.012.
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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.
Sevket Gorgulu, MD study chair
Acibadem University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing radial access site and femoral access site in people with Chronic Coronary Occlusion, run by Acibadem University at 4 sites in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural success (time frame: 24 hours). 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 NCT03265769, which also lists 1 linked publication.
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 13 Sep 2021.