Angina PectorisNCT02158455
Vein vs Arterial Grafts for Coronary Artery Bypass Grafting Surgery
A study testing NT SVG grafts in people with Angina Pectoris, run by Region Örebro County at 1 site in Sweden.
Trial summary
The investigators have developed a novel technique for saphenous vein graft harvesting for coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of surrounding tissue. Read more about this study
- Who is it for?
- Ages Up to 65 years
- Conditions the study is for
- Angina Pectoris
- What is being tested?
- NT SVG grafts
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2004to Dec 2014
- 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 Up to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Three vessel coronary artery disease
Who cannot join
- 65 years or older
- Elevated creatinine
- Raynauds disease
- Vein stripping
Trial locations and contacts
1 site in 1 country.
About this study
Official title: No-touch Saphenous Vein Grafts vs Radial Artery Grafts; A Randomized Trial.
The investigators have developed a novel technique for saphenous vein graft harvesting for coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of surrounding tissue. A randomized trial has shown a significantly higher patency rate for vein grafts harvested with this new methode compared to conventional harvesting technique 8.5 years after surgery (90 vs 76 %). In 2004 the investigators started a prospective randomized trial comparing patency between vein grafts harvested with surrounding tissue and radial artery grafts. The result showed that vein grafts harvested with surrounding tissue had a significantly higher patency rate compared to radial artery grafts 3 years after surgery (98 vs 84 %). The present study is a long-term follow-up (8 years) of the patients included in the second randomized trial. The hypothesis is that vein grafts harvested with surrounding tissue have a significantly higher patency rate compared to radial artery grafts 8 years after surgery.
- Conditions
- Angina Pectoris
- Being tested
- NT SVG grafts
- Keywords
- CABG, Saphenous vein, Radial artery
- Medical subject headings
- Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NT SVG graftsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| NT SVG grafts | Experimental | NT SVG randomized for revascularization of left or right coronary territory Receives: Procedure: NT SVG grafts |
| RA grafts | Active comparator | RA grafts randomized for revascularization of left or right coronary territory Receives: Procedure: NT SVG grafts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Graft patency
The grafts will be categorized as either "open" or "closed". A stenosis of the graft exceeding 70 % of the lumen diameter will be considered as "closed".
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study startFeb 2004
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angina PectorisStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mats Dreifaldt, Region Örebro County
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158455
- Sponsor's protocol ID
- NTSVGRA
- Status last verified
- Jun 2014
- First submitted
- 30 Apr 2014
- Last updated
- 6 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- No-touch Saphenous Vein Grafts vs Radial Artery Grafts; A Randomized Trial.
- ClinicalTrials.gov ID
- NCT02158455
- Acronym / sponsor ID
- NTSVGRA
- Conditions
- Angina Pectoris
- Keywords
- CABG, Saphenous vein, Radial artery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- Feb 2004
- Primary completion
- Dec 2014 (estimated)
- First posted
- 6 Jun 2014 (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 investigators have developed a novel technique for saphenous vein graft harvesting for coronary artery bypass grafting (CABG) where the graft is harvested with a pedicle of surrounding tissue. A randomized trial has shown a significantly higher patency rate for vein grafts harvested with this new methode compared to conventional harvesting technique 8.5 years after surgery (90 vs 76 %). In 2004 the investigators started a prospective randomized trial comparing patency between vein grafts harvested with surrounding tissue and radial artery grafts. The result showed that vein grafts harvested with surrounding tissue had a significantly higher patency rate compared to radial artery grafts 3 years after surgery (98 vs 84 %). The present study is a long-term follow-up (8 years) of the patients included in the second randomized trial. The hypothesis is that vein grafts harvested with surrounding tissue have a significantly higher patency rate compared to radial artery grafts 8 years after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NT SVG grafts | Experimental | Procedure: NT SVG graftsNT SVG randomized for revascularization of left or right coronary territory |
| RA grafts | Active comparator | Procedure: NT SVG graftsRA grafts randomized for revascularization of left or right coronary territory |
Who may qualify
- Ages
- Up to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Three vessel coronary artery disease
Key exclusion criteria (4 listed)
- 65 years or older
- Elevated creatinine
- Raynauds disease
- Vein stripping
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 |
|---|---|---|
| NT SVG grafts | Procedure or surgery | NT SVG grafts, RA grafts |
Primary outcome
Graft patency
Time frame: 5 months
The grafts will be categorized as either "open" or "closed". A stenosis of the graft exceeding 70 % of the lumen diameter will be considered as "closed".
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NT SVG grafts in people with Angina Pectoris, run by Region Örebro County at 1 site in Sweden.
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 4 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: status not confirmed, as of the sponsor's last update on 6 Jun 2014. 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 Sweden. 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?
Results are not available in the source record.
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?
Graft patency (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2014.