Peripheral Arterial DiseaseNCT01095237
Clinical Pilot-Study of ProEndoTecc Vascular Grafts as Superficial Femoral Artery Bypass / Interponate
A study testing ProEndoTecc Vascular Graft in people with Peripheral Arterial Disease and Peripheral Vascular Disease, run by NonWoTecc Medical GmbH at 12 sites in Germany.
Trial summary
This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as superficial femoral artery bypass/interponate. The aim of this study is to demonstrate safety of implantation, patency and durability of a new type of vascular graft. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Peripheral Arterial Disease, Peripheral Vascular Disease
- What is being tested?
- ProEndoTecc Vascular Graft
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 12 sitesGermany
- Study dates
- Mar 2010to Nov 2012
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male patient from 18 to 89 years of age
- Superficial femoral artery occlusion from 5 to 40 cm in length (above the knee joint),
- Patient must present with intermittent claudication, with resistance to medical therapy and exercise or critical ischemia,
- Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease,
- Women of childbearing age must have negative pregnancy test prior to inclusion
Who cannot join
- Bleeding diathesis
- Patient has known coagulation disorders including hypercoagulability
- Presence of one or several previously placed endo-prosthesis or grafts in the diseased extremity (below iliacs)
- Other than 6-8 mm diameter graft is needed.
- Patients PAD state is in Fontaine Grade IV, Rutherford Grade 6 (Patient has active infection or pronounced necrosis in the region of graft placement)
- Patient has an acute embolic arterial occlusion
Show all 18Show fewer
- Life-expectancy less than 6 month due to co-morbidity or other situation that would make the patient an unlikely candidate for follow-up visits
- Patient had percutaneous transluminal angioplasty at the implant site within the previous 30 days
- Participation in another clinical study less than 30 days prior to inclusion
- Patient is in need of, or is scheduled for, a cardiac surgical procedure or a different vascular surgical procedure
- Pregnant or breast feeding female patients
- Multiple graft (implant) needed
- Patients unable to understand the full meaning of the informed consent
- Subjects who, in the opinion of the investigator, will be inappropriate for inclusion into this trial or will not comply with requirements of the study
- Subjects who are imprisoned (according to MPG §20.3)
- Patients who are lawfully kept in an institution
- Participation in this trial at an earlier stage
- Current participation in another clinical trial
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Germany12 sites
Luisenhospital Dpt. of Vascular Surgery
Aachen, North Rhine-Westphalia, 50937
Gefaesschirurgische Klinik St-Marienhospital Bonn
Bonn, North Rhine-Westphalia, 53115
Knappschaftskrankenhaus Bottrop Dpt. of Vascular Surgery
Bottrop, North Rhine-Westphalia, 46242
Clinic and Polyclinic for Vascular Surgery
Cologne, North Rhine-Westphalia, 50937
Klinikum Deggendorf, Dpt. of Vascular- and Endovascular Surgery
Deggendorf, Bavaria, 94469
Staedtisches Klinikum Karlsruhe gGmbH
Karlsruhe, Baden-Wurttemberg, 76133
Klinik fuer Gefaesschirurgie St-Bonifatius-Hospital Lingen
Lingen, Lower Saxony, 49808
Evangelisches Krankenhaus Dpt. of Vascular Surgery
Mülheim, North Rhine-Westphalia, 45468
Hospital Muenchen-Pasing
Munich, Bavaria, 81241
Klinikum Nuernberg Sued Dpt. of Vascular Surgery
Nuremberg, Bavaria, 90471
Krankenhaus Barmherzige Brüder, Dpt. of Vascular Surgery
Regensburg, Bavaria, 93049
Sana Clinic Remscheid Dpt. of Vascular Surgery
Remscheid, North Rhine-Westphalia, 42859
About this study
Official title: Multicenter, Clinical Pilot-Study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as Superficial Femoral Artery Bypass/Interponate
This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as superficial femoral artery bypass/interponate.
The aim of this study is to demonstrate safety of implantation, patency and durability of a new type of vascular graft.
- Being tested
- ProEndoTecc Vascular Graft
- Keywords
- Peripheral Arterial Disease, Peripheral Vascular Disease, PAD, vascular prosthesis, revascularization, patency, blood vessel, Rutherford, ABI, Ankle Brachial Index, Vascular Graft, Carbothane, ProEndoTecc, implantation
- Medical subject headings
- Peripheral Arterial Disease, Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProEndoTecc Vascular GraftDevice
Also called ProEndoTecc Vascular Graft Prosthesis
Implantation of the device as an interponate / bypass of the superficial femoral artery
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency of device
Primary Patency of treated arterial segment at 6 month after intervention. Primary Patency is defined by objective demonstration via colour-coded Doppler sonography or angiography that the entire length of the graft remain patent with no further intervention required for symptomatic recurrent disease.
In case this information is not available, primary patency might be declared, if any the following criteria are fulfilled: Present ABI increased of ≥0.1 compared to preoperative status Present PAD-Grade according to Rutherford increased by one degree Palpable pulse distal of prosthesis.
Measured: 6, 12, 24 months after implatation
Secondary outcomes (1)
Guarding Safety variables
- Peri-interventional monitoring resp. haemorrhages, haematomas
- Aneurysm in the grafted segment
- Fistula to the grafted segment
- Fibrosis at and around implantation site
- Death
Measured: 6,12, 24 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2010 (estimated)
- Study startMar 2010
- Primary completionNov 2012
- Study completionNov 2012
Why it stopped: Study has been halted due to safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- NonWoTecc Medical GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- MDT Medical Device Testing GmbH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01095237
- Sponsor's protocol ID
- mdt-09k006
- Status last verified
- Jul 2014
- First submitted
- 23 Mar 2010
- Last updated
- 9 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Clinical Pilot-Study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as Superficial Femoral Artery Bypass/Interponate
- ClinicalTrials.gov ID
- NCT01095237
- Acronym / sponsor ID
- mdt-09k006
- Keywords
- Peripheral Arterial Disease, Peripheral Vascular Disease, PAD, vascular prosthesis, revascularization, patency, blood vessel, Rutherford
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study has been halted due to safety reasons
- Enrolment
- 33 participants (actual)
- Lead sponsor
- NonWoTecc Medical GmbHIndustry (pharma, biotech, devices)
- Collaborators
- MDT Medical Device Testing GmbH
- Study start
- Mar 2010
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 30 Mar 2010 (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.
This is a multi-center, clinical pilot-study of ProEndoTecc Vascular Grafts (6, 7 or 8 mm Diameter) as superficial femoral artery bypass/interponate.
The aim of this study is to demonstrate safety of implantation, patency and durability of a new type of vascular graft.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female or male patient from 18 to 89 years of age
- Superficial femoral artery occlusion from 5 to 40 cm in length (above the knee joint),
- Patient must present with intermittent claudication, with resistance to medical therapy and exercise or critical ischemia,
- Patient has Rutherford grade 3, 4, or 5 occlusive vascular disease,
- Women of childbearing age must have negative pregnancy test prior to inclusion
Key exclusion criteria (18 listed)
- Bleeding diathesis
- Patient has known coagulation disorders including hypercoagulability
- Presence of one or several previously placed endo-prosthesis or grafts in the diseased extremity (below iliacs)
- Other than 6-8 mm diameter graft is needed.
- Patients PAD state is in Fontaine Grade IV, Rutherford Grade 6 (Patient has active infection or pronounced necrosis in the region of graft placement)
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 |
|---|---|---|
| ProEndoTecc Vascular GraftAlso: ProEndoTecc Vascular Graft ProsthesisImplantation of the device as an interponate / bypass of the superficial femoral artery | Device | – |
Primary outcome
Primary patency of device
Time frame: 6, 12, 24 months after implatation
Primary Patency of treated arterial segment at 6 month after intervention. Primary Patency is defined by objective demonstration via colour-coded Doppler sonography or angiography that the entire length of the graft remain patent with no further intervention required for symptomatic recurrent disease. In case this information is not available, primary patency might be declared, if any the following criteria are fulfilled: Present ABI increased of ≥0.1 compared to preoperative status Present PAD-Grade according to Rutherford increased by one degree Palpable pulse distal of prosthesis.
1 secondary outcome
Guarding Safety variables
Time frame: 6,12, 24 months after implantation
Results and safety
The study was stopped early (reason given: Study has been halted due to safety reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 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.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ProEndoTecc Vascular Graft in people with Peripheral Arterial Disease and Peripheral Vascular Disease, run by NonWoTecc Medical GmbH at 12 sites in Germany.
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 5 inclusion and 18 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: stopped early, as of the sponsor's last update on 9 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. 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 was stopped early (reason given: Study has been halted due to safety reasons). 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?
Primary patency of device (time frame: 6, 12, 24 months after implatation). 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 9 Jul 2014.