Intermittent ClaudicationPhase 3DaDaNCT00523263
Dacron vs Dardik for Fem-Pop Bypass
A Phase 3 study testing heparin-bonded and collagen coated polyster and Human umbilical vein femoro-popliteal bypass in people with Intermittent Claudication and Arterial Occlusive Diseases, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Clinical trial for the comparison of long-term patency of heparin-bonded Dacron and human umbilical vein vascular prostheses in above-knee femoro-popliteal bypass surgery. Read more about this study
- Who is it for?
- Ages 31 to 89 years
- Conditions the study is for
- Intermittent Claudication, Arterial Occlusive Diseases, Atheroslerosis
- What is being tested?
- heparin-bonded and collagen coated polyster and Human umbilical vein femoro-popliteal bypass
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- Not given
- Where
- 1 siteNetherlands
- Study dates
- Jan 1996to Apr 2007
- Phase
- Phase 3
- 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 31 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 31 to 89
- intermittent claudication
- ABI below 0.8
Who cannot join
- non elective surgery
- life expectancy below 2 yrs
- contraindication for anticoagulant therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Heparin Bonded and Collagen Coated Polyester or Human Umbilical Vein for Femoropopliteal Bypass: a Prospective Randomised Multicentre Trial.
Clinical trial for the comparison of long-term patency of heparin-bonded Dacron and human umbilical vein vascular prostheses in above-knee femoro-popliteal bypass surgery.
- Being tested
- heparin-bonded and collagen coated polyster, Human umbilical vein femoro-popliteal bypass
- Medical subject headings
- Intermittent Claudication, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heparin-bonded and collagen coated polysterDevice
femoro-popliteal bypass
Human umbilical vein femoro-popliteal bypassDevice
| Study group | Role | What they receive |
|---|---|---|
| Dacron | Active comparator | Patients receiving polyester above-knee femoro-popliteal bypass Receives: Device: heparin-bonded and collagen coated polyster |
| HUV | Active comparator | patients receiving HUV femoro-popliteal bypass Receives: Device: Human umbilical vein femoro-popliteal bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary and primary-assisted bypass patency
Measured: 1 - 5 yrs
Secondary outcomes (1)
Secondary bypass patency
Measured: 1 - 5 yrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2007 (estimated)
- Study startJan 1996
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intermittent ClaudicationStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Investigators
- J. Adam van der Vliet, MD, PhD, Principal investigator, Radboud University Medical Center Nijmegen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00523263
- Sponsor's protocol ID
- DaDa-trial
- Acronym
- DaDa
- Status last verified
- Aug 2007
- First submitted
- 30 Aug 2007
- Last updated
- 31 Aug 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Scharn DM, Oyen WJ, Klemm PL, Verhofstad AA, van der Vliet JA. Thrombogenicity and related biological properties of heparin bonded collagen coated polyester and human umbilical vein prosthetic vascular grafts. J Surg Res. 2006 Aug;134(2):182-9. doi: 10.1016/j.jss.2006.01.025. Epub 2006 Mar 20.
PubMed 16542682Scharn DM, Oyen WJ, Klemm PL, Wijnen MH, vanderVliet JA. Assessment of prosthetic vascular graft thrombogenicity using the technetium-99m labeled glycoprotein IIb/IIIa receptor antagonist DMP444 in a dog model. Cardiovasc Surg. 2002 Dec;10(6):566-9. doi: 10.1177/096721090201000609.
PubMed 12453688Dirven M, Scharn DM, Blankensteijn JD, van der Vliet JA. Preservation for future use of the autologous saphenous vein during femoro-popliteal bypass surgery is inexpedient. Eur J Vasc Endovasc Surg. 2008 Oct;36(4):420-3. doi: 10.1016/j.ejvs.2008.06.012.
PubMed 18675557
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin Bonded and Collagen Coated Polyester or Human Umbilical Vein for Femoropopliteal Bypass: a Prospective Randomised Multicentre Trial.
- ClinicalTrials.gov ID
- NCT00523263
- Acronym / sponsor ID
- DaDa / DaDa-trial
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Jan 1996
- Study completion
- Apr 2007 (actual)
- First posted
- 31 Aug 2007 (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.
Clinical trial for the comparison of long-term patency of heparin-bonded Dacron and human umbilical vein vascular prostheses in above-knee femoro-popliteal bypass surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dacron | Active comparator | Device: heparin-bonded and collagen coated polysterPatients receiving polyester above-knee femoro-popliteal bypass |
| HUV | Active comparator | Device: Human umbilical vein femoro-popliteal bypasspatients receiving HUV femoro-popliteal bypass |
Who may qualify
- Ages
- 31 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age 31 to 89
- intermittent claudication
- ABI below 0.8
Key exclusion criteria (3 listed)
- non elective surgery
- life expectancy below 2 yrs
- contraindication for anticoagulant therapy
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 |
|---|---|---|
| heparin-bonded and collagen coated polysterfemoro-popliteal bypass | Device | Dacron |
| Human umbilical vein femoro-popliteal bypass | Device | HUV |
Primary outcome
Primary and primary-assisted bypass patency
Time frame: 1 - 5 yrs
1 secondary outcome
Secondary bypass patency
Time frame: 1 - 5 yrs
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 31 Aug 2007.
- Background: PubMed 16542682Scharn DM, Oyen WJ, Klemm PL, Verhofstad AA, van der Vliet JA. Thrombogenicity and related biological properties of heparin bonded collagen coated polyester and human umbilical vein prosthetic vascular grafts. J Surg Res. 2006 Aug;134(2):182-9. doi: 10.1016/j.jss.2006.01.025. Epub 2006 Mar 20.
- Background: PubMed 12453688Scharn DM, Oyen WJ, Klemm PL, Wijnen MH, vanderVliet JA. Assessment of prosthetic vascular graft thrombogenicity using the technetium-99m labeled glycoprotein IIb/IIIa receptor antagonist DMP444 in a dog model. Cardiovasc Surg. 2002 Dec;10(6):566-9. doi: 10.1177/096721090201000609.
- Derived from this study: PubMed 18675557Dirven M, Scharn DM, Blankensteijn JD, van der Vliet JA. Preservation for future use of the autologous saphenous vein during femoro-popliteal bypass surgery is inexpedient. Eur J Vasc Endovasc Surg. 2008 Oct;36(4):420-3. doi: 10.1016/j.ejvs.2008.06.012.
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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.
J. Adam van der Vliet, MD, PhD principal investigator
Radboud University Medical Center Nijmegen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing heparin-bonded and collagen coated polyster and Human umbilical vein femoro-popliteal bypass in people with Intermittent Claudication and Arterial Occlusive Diseases, run by Radboud University Medical Center at 1 site in Netherlands.
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 3 inclusion and 3 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 31 Aug 2007. 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 Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Primary and primary-assisted bypass patency (time frame: 1 - 5 yrs). 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 NCT00523263, which also lists 3 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 31 Aug 2007.