Coronary Artery DiseaseNCT02983721
Trans Radial Versus Transfemoral Route for Coronary Angiography
A study testing transradial and Transfemoral in people with Coronary Artery Disease, run by Sheri Kashmir Institute of Medical Sciences.
Trial summary
The purpose of this study was to assess and compare the feasibility, success and safety of Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic coronary angiography and coronary interventions, in terms of procedural time, access time, fluoroscopy time, procedural failure, … Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- transradial and Transfemoral
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Aug 2015
- 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 20 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnostic angiography of coronary vessels, PCI
Who cannot join
- Patients with impaired renal function tests.
- Lack of informed consent.
- Severe infection.
- Previous contrast allergy.
- Severe intrinsic/iatrogenic caogulopathy INR>2.
- Abnormal modified Allen's test.
About this study
Official title: Comparison Between Transradial and Transfemoral Routes of Coronary Angiography and Interventions
The purpose of this study was to assess and compare the feasibility, success and safety of Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic coronary angiography and coronary interventions, in terms of procedural time, access time, fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital, Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of vessel, MACE, Stroke and others.
Read the detailed description
Background: PCI has been done traditionally through transfemoral route. But now transradial and transbrachial routes are also coming up in practice. We compared transradial versus transfemoral routes for ease of operability, time for procedure, complications, and failure rates through a prospective study. Methods: 400 Patients admitted in department of cardiology for percutaneous interventions were enrolled in the study. 200 patients were assigned to each group randomly. A single team did all the procedures. Pre procedure, intra procedure and post procedure data of all the patients was collected, tabulated and analysed properly.
The variables studied include Access time ,Fluoroscopy time and overall procedure time, post procedure complications( ecchymosis ,Thrombophelibites, Hematoma, procedure access bleed), Failure rates,post procedure myocardial infarction, stroke, acute renal failure and infections.
- Conditions
- Coronary Artery Disease
- Being tested
- transradial, Transfemoral
- 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.
transradialProcedure or surgery
transradial route for coronary angiography and PCI
TransfemoralProcedure or surgery
transfemoral route for coronary angiography and PCI
| Study group | Role | What they receive |
|---|---|---|
| Transfemoral | Active comparator | in case of transfemoral approach our preference was to use right femoral route. The groin was prepared and draped and the site was punctured for femoral access after anesthetizing the skin with 2-4 ml of 1% lignocaine. Once the femoral puncture was done 6F sheath of Cordis variety was introduced and 6F Judkins, catheter was introduced and it was guided under fluoroscopic guidance through the aortic route. Receives: Procedure: transradial; Procedure: Transfemoral |
| Transradial | Active comparator | Our preference was to use the right radial and right femoral routes as they are nearest to operator while facing cardiac monitors, in our hospital. For the radial approach, the wrist was sterilized and draped in usual fashion. Hyperextension over an arm board was done and skin over the puncture site was anesthetized with 2 - 3 ml of 1% lignocaine. A small scaled incision was performed 1 cm proximal to styloid process of radius where arterial pulse was best felt. The radial artery was punctured with a 21 G needle and 6 F sheath (Cardis, Terumo) were introduced into the artery, using Seldinger technique. All patients received verapamil (5mg) to reduce radial artery spasm. Heparin (weight adjusted) was used only in PCIs to prevent artery occlusion and not in elective diagnostic coronary studies. Long 0.038 Terumo guide wire was used under fluoroscopic guidance. Receives: Procedure: transradial; Procedure: Transfemoral |
What is being measured
The primary outcome is the main question the study is designed to answer.
Access time
Access time for the procedures
Measured: 4 years
Fluoroscopy time
measure of radiation exposure
Measured: 4 years
Procedure time
time taken to do the full procedure
Measured: 4 years
hospital stay
time period the patient stayed in the hospital
Measured: 4 years
Secondary outcomes (4)
hematoma
hematoma development at the site of puncture
Measured: 4 years
pseudoaneurysm
local complication at the access site
Measured: 4 years
bleeding
at the access site
Measured: 4 years
Access site failure
failure to gain access for the procedure
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startAug 2011
- Primary completionAug 2015
- Study completionAug 2015
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheri Kashmir Institute of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Khalid Changal, Sheri Kashmir Institute of Medical Sciences
- Investigators
- Fayaz Bhat, MBBS, MD, Study chair, Ministry of Health, Jammu and Kashmir, India.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983721
- Sponsor's protocol ID
- car003421
- Other IDs
- PG thesis 003421
- Status last verified
- Dec 2016
- First submitted
- 1 Dec 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: can be shared by email
Publications
Bhat FA, Changal KH, Raina H, Tramboo NA, Rather HA. Transradial versus transfemoral approach for coronary angiography and angioplasty - A prospective, randomized comparison. BMC Cardiovasc Disord. 2017 Jan 11;17(1):23. doi: 10.1186/s12872-016-0457-2.
PubMed 28077091
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Transradial and Transfemoral Routes of Coronary Angiography and Interventions
- ClinicalTrials.gov ID
- NCT02983721
- Acronym / sponsor ID
- car003421
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Sheri Kashmir Institute of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Dec 2016 (estimated)
- 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 purpose of this study was to assess and compare the feasibility, success and safety of Transradial approach (TRA) verses Transfemoral approach (TFA) for diagnostic and therapeutic coronary angiography and coronary interventions, in terms of procedural time, access time, fluoroscopy time, procedural failure, , length of hospital stay in terms of days in hospital, Complications in terms of thrombophlebitis, hematoma, ecchymosis, infections thrombosis of vessel, MACE, Stroke and others.
Detailed description
Background: PCI has been done traditionally through transfemoral route. But now transradial and transbrachial routes are also coming up in practice. We compared transradial versus transfemoral routes for ease of operability, time for procedure, complications, and failure rates through a prospective study. Methods: 400 Patients admitted in department of cardiology for percutaneous interventions were enrolled in the study. 200 patients were assigned to each group randomly. A single team did all the procedures. Pre procedure, intra procedure and post procedure data of all the patients was collected, tabulated and analysed properly.
The variables studied include Access time ,Fluoroscopy time and overall procedure time, post procedure complications( ecchymosis ,Thrombophelibites, Hematoma, procedure access bleed), Failure rates,post procedure myocardial infarction, stroke, acute renal failure and infections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transfemoral | Active comparator | Procedure: transradial, Procedure: Transfemoralin case of transfemoral approach our preference was to use right femoral route. The groin was prepared and draped and the site was punctured for femoral access after anesthetizing the skin with 2-4 ml of 1% lignocaine. Once the femoral puncture was done 6F sheath of Cordis variety was introduced and 6F Judkins, catheter was introduced and it was guided under fluoroscopic guidance through the aortic route. |
| Transradial | Active comparator | Procedure: transradial, Procedure: TransfemoralOur preference was to use the right radial and right femoral routes as they are nearest to operator while facing cardiac monitors, in our hospital. For the radial approach, the wrist was sterilized and draped in usual fashion. Hyperextension over an arm board was done and skin over the puncture site was anesthetized with 2 - 3 ml of 1% lignocaine. A small scaled incision was performed 1 cm proximal to styloid process of radius where arterial pulse was best felt. The radial artery was punctured with a 21 G needle and 6 F sheath (Cardis, Terumo) were introduced into the artery, using Seldinger technique. All patients received verapamil (5mg) to reduce radial artery spasm. Heparin (weight adjusted) was used only in PCIs to prevent artery occlusion and not in elective diagnostic coronary studies. Long 0.038 Terumo guide wire was used under fluoroscopic guidance. |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- diagnostic angiography of coronary vessels, PCI
Key exclusion criteria (6 listed)
- Patients with impaired renal function tests.
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 |
|---|---|---|
| transradialtransradial route for coronary angiography and PCI | Procedure or surgery | Transfemoral, Transradial |
| Transfemoraltransfemoral route for coronary angiography and PCI | Procedure or surgery | Transfemoral, Transradial |
Primary outcome
Access time
Time frame: 4 years
Access time for the procedures
Fluoroscopy time
Time frame: 4 years
measure of radiation exposure
Procedure time
Time frame: 4 years
time taken to do the full procedure
hospital stay
Time frame: 4 years
time period the patient stayed in the hospital
4 secondary outcomes
hematoma
Time frame: 4 years
pseudoaneurysm
Time frame: 4 years
bleeding
Time frame: 4 years
Access site failure
Time frame: 4 years
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 6 Dec 2016.
- Derived from this study: PubMed 28077091Bhat FA, Changal KH, Raina H, Tramboo NA, Rather HA. Transradial versus transfemoral approach for coronary angiography and angioplasty - A prospective, randomized comparison. BMC Cardiovasc Disord. 2017 Jan 11;17(1):23. doi: 10.1186/s12872-016-0457-2.
- Individual participant dataSharing planned: Yes. can be shared by email
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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.
Fayaz Bhat, MBBS, MD study chair
Ministry of Health, Jammu and Kashmir, India.
Questions about this trial
What is this clinical trial studying?
A study testing transradial and Transfemoral in people with Coronary Artery Disease, run by Sheri Kashmir Institute of Medical Sciences.
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 6 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 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Access time (time frame: 4 years). The study lists 4 primary outcomes in all. 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 NCT02983721, 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 6 Dec 2016.