Peripheral Vascular DiseaseNCT00736086
RISE: A Clinical Evaluation of the StarClose™ Vascular Closure System
An observational study of Peripheral Vascular Disease and Cardiovascular Disease, run by Abbott Medical Devices at 11 sites in United States.
Trial summary
To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Peripheral Vascular Disease, Cardiovascular Disease
- What is being tested?
- Vessel Closure (StarClose™)
- Type of treatment
- Medical device
- How many people
- 165 participants
- Where
- 11 sitesUnited States
- Study dates
- Mar 2006to Dec 2006
- Phase
- Observational
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects who are ambulated early post-percutaneous, cardiac or peripheral vascular, diagnostic catheterization procedure
Who may be able to join
- Subject must be 18-85.
- Subject must be an acceptable candidate for an elective,non-emergent diagnostic procedure performed percutaneously via the common femoral artery through either a 5F or 6F procedural sheath.
- Subject is an acceptable candidate for emergent vascular surgery.
- Subject agrees to follow-up evaluations to assess for complications related to femoral access site.
- If among the 50 ultrasound sub-study Subjects enrolled,Subject agrees to have an ultrasound of femoral artery performed post-procedure during the 30 ± 7 days follow-up visit.
- Subject or legal representative has been informed of the nature of the study and agrees to provisions and has provided written informed consent as approved by the Institutional Review Board of respective clinical site.
Who cannot join
- History of bleeding diathesis or coagulopathy including hemophilia, von Willebrand's disease, and/or a current, known platelet count <100,000 cells/mm3, or baseline INR > 1.7.
- Body Mass Index (BMI) ³ 35 kg/m2.
- Presence of significant anemia (Hgb < 10 g/dL, Hct < 30%).
- Advanced Subject refusal of blood transfusions, should transfusion become necessary.
- Participation in another trial of an investigational drug or device that has not yet completed follow-up requirements.
- Pregnant or lactating female.
Show all 32Show fewer
- Clinically severe peripheral vascular disease in the ipsilateral limb, defined as severe claudication (walking < 100 feet), weak or absent pulses, or lower extremity vascular graft.
- History of ipsilateral femoral arterial puncture within previous three months or history of vascular closure device deployment in ipsilateral femoral artery at any time.
- Subject has unilateral or bilateral lower extremity amputation(s).
- Subject is unable to routinely walk at least 20 feet without assistance.
- Subject has an active systemic or cutaneous infection or inflammation.
- Subject has a pre-existing severe non-cardiac systemic disease or illness with a life expectancy of < 30 days.
- Subject has already participated in this Study.
- Subject has known allergy to nitinol.
- Access Site Exclusion-(Evaluated via Limited Femoral Angiogram)
- Pseudoaneurysm or AV fistula present in ipsilateral femoral artery prior to arterial closure.*
- Puncture distal to the common femoral artery bifurcation or above the inguinal ligament which is typically defined by the inferior border of the inferior epigastric artery on sheath angiogram or the upper third of the femoral head by plain fluoroscopy.*
- The arterial lumen diameter at the arteriotomy site is < 5mm by visual estimate.*
- Angiographic evidence of calcified lesions at the arteriotomy site.*
- Difficulty inserting the introducer sheath at the start of the catheterization procedure due to vessel scarring or tortuosity, or anterior/posterior wall femoral artery punctures or greater than 2 ipsilateral arterial puncture attempts at the time of the percutaneous procedure.
- Known iliac or femoral stenosis >50% or previous bypass surgery or stent placement in the vicinity of the puncture site.
- Planned percutaneous procedure (diagnostic or intervention) in ipsilateral femoral artery prior to the 30-day follow-up evaluation.
- Subject has intra-procedural bleeding around the access site.
- Presence or previous use of an intra-aortic balloon pump through the existing arterial puncture site.
- Procedural Exclusion:
- Low molecular weight heparin administration within 8 hours of enrollment.
- For cases where anticoagulants are used, ACT level > 350 seconds at time of enrollment.
- Subject is determined to require treatment that will extend hospitalization (e.g. ---Subject is undergoing CABG surgery or staged PTCA).
- Persistent hypertension (SBP >180 or DBP >110 mm Hg) unresponsive to medical -therapy at time of enrollment.
- Placement of an ipsilateral femoral venous sheath during procedure.
- Presence of clinically significant hematoma (> 6 cm) in ipsilateral femoral artery prior to arterial closure.
- Placement of introducer sheath < 5F or > 6F during procedure.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Fuqua Heart Center/ Piedmont Hospital
Atlanta, Georgia, 30309
Bay Regional Medical Center
Bay City, Michigan, 48708
New York Methodist Hospital
Brooklyn, New York, 11215
Buffalo Heart group
Buffalo, New York, 14203
North Ohio Research LTD Elyria Regional Medical
Elyria, Ohio, 44035
The Care Group LLC (St. Vincent's Hospital)
Indianapolis, Indiana, 46260
St. Luke's Hospital
Kansas City, Missouri, 64111
Scripps Memorial Hospital
La Jolla, California, 92037
Minneapolis Heart Institute Foundation/Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Heart Care Midwest (OSF/St Francis)
Peoria, Illinois, 61603
Drexel University College of Medicine Hahnemann
Philadelphia, Pennsylvania, 19102
About this study
Official title: A Post-Market, Prospective, Multi-Center, Study to Evaluate Safety and Efficacy of the StarClose™ Vascular Closure System in Patients Who Are Ambulated Early Post-Diagnostic Catheterization
To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure.
Read the detailed description
To evaluate the StarClose™ VCS in the femoral artery in subjects who are ambulated early post-percutaneous cardiac or peripheral vascular, diagnostic catheterization procedure. The clinical use of vascular closure devices for rapid hemostasis after femoral access was first reported in 1991. 18 participants may be ambulated almost immediately after diagnostic coronary angiography and discharged many hours earlier than currently practiced in most centers utilizing a supine restriction period of 6 hours after diagnostic catheterization.14 After coronary interventions, participant comfort is additionally increased by immediate sheath removal.
This early ambulation study is an evaluation of a clip-based technology, which achieves vascular hemostasis with the use of a novel extravascular Nitinol clip to provide an immediate mechanical closure that does not depend upon the body's clotting system. The procedures will be performed in participants who meet specific entrance criteria.
- Being tested
- Vessel Closure (StarClose™)
- Keywords
- femoral artery, post-percutaneous cardiac catheterization, post-percutaneous peripheral vascular catheterization, post-percutaneous diagnostic catheterization, early ambulation, vascular closure
- Medical subject headings
- Peripheral Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vessel Closure (StarClose™)Device
| Study group | Role | What they receive |
|---|---|---|
| 1 | Subjects who are ambulated early post-percutaneous, cardiac or peripheral vascular, diagnostic catheterization procedures with the use of StarClose® Vascular Closure System in the femoral artery after diagnostic catheterization procedure. Receives: Device: Vessel Closure (StarClose™) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2008 (estimated)
- Study startMar 2006
- Primary completionNov 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (28)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- William Kussmaul, MD, Principal investigator, Drexel University/Hahnemann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00736086
- Sponsor's protocol ID
- AVD-640-0057
- Status last verified
- Aug 2008
- First submitted
- 13 Aug 2008
- Last updated
- 15 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Krone RJ, Johnson L, Noto T. Five year trends in cardiac catheterization: a report from the Registry of the Society for Cardiac Angiography and Interventions. Cathet Cardiovasc Diagn. 1996 Sep;39(1):31-5. doi: 10.1002/ccd.1810390102.
PubMed 8874942Waksman R, Scott NA, Ghazzal ZM, Mays R, Frerichs FA, Petersen JY, King SB 3rd. Randomized comparison of flexible versus nonflexible femoral sheaths on patient comfort after angioplasty. Am Heart J. 1996 Jun;131(6):1076-8. doi: 10.1016/s0002-8703(96)90079-4.
PubMed 8644584Bogart DB, Bogart MA, Miller JT, Farrar MW, Barr WK, Montgomery MA. Femoral artery catheterization complications: a study of 503 consecutive patients. Cathet Cardiovasc Diagn. 1995 Jan;34(1):8-13. doi: 10.1002/ccd.1810340304.
PubMed 7728861Christensen B, Lacarella C, Manion R, Bruhn-Ding B, Meyer S, Wilson R. Sandbags do not prevent complications after catheterization. Circulation 90:I-205, 1994.
Pracyk JB, Wall TC, Longabaugh JP, Tice FD, Hochrein J, Green C, Cox G, Lee K, Stack RS, Tcheng JE. A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. Am J Cardiol. 1998 Apr 15;81(8):970-6. doi: 10.1016/s0002-9149(98)00074-5.
PubMed 9576155Resar JR, Prewitt KC, Wolff MR, Blumenthal R, Raqueno JV, Brinker JA. Percutaneous transluminal coronary angioplasty through 6F diagnostic catheters: a feasibility study. Am Heart J. 1993 Jun;125(6):1591-6. doi: 10.1016/0002-8703(93)90745-u.
PubMed 8498298Cragg AH, Nakagawa N, Smith TP, Berbaum KS. Hematoma formation after diagnostic angiography: effect of catheter size. J Vasc Interv Radiol. 1991 May;2(2):231-3. doi: 10.1016/s1051-0443(91)72287-2.
PubMed 1799761Waksman R, King SB 3rd, Douglas JS, Shen Y, Ewing H, Mueller L, Ghazzal ZM, Weintraub WS. Predictors of groin complications after balloon and new-device coronary intervention. Am J Cardiol. 1995 May 1;75(14):886-9. doi: 10.1016/s0002-9149(99)80681-x.
PubMed 7732995Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989 Jan;16(1):3-7. doi: 10.1002/ccd.1810160103.
PubMed 2912567Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study. J Am Coll Cardiol. 1997 May;29(6):1269-75. doi: 10.1016/s0735-1097(97)00064-8.
PubMed 9137223Bertrand ME, Legrand V, Boland J, Fleck E, Bonnier J, Emmanuelson H, Vrolix M, Missault L, Chierchia S, Casaccia M, Niccoli L, Oto A, White C, Webb-Peploe M, Van Belle E, McFadden EP. Randomized multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting. The full anticoagulation versus aspirin and ticlopidine (fantastic) study. Circulation. 1998 Oct 20;98(16):1597-603. doi: 10.1161/01.cir.98.16.1597.
PubMed 9778323Leon MB, Baim DS, Popma JJ, Gordon PC, Cutlip DE, Ho KK, Giambartolomei A, Diver DJ, Lasorda DM, Williams DO, Pocock SJ, Kuntz RE. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators. N Engl J Med. 1998 Dec 3;339(23):1665-71. doi: 10.1056/NEJM199812033392303.
PubMed 9834303Dick RJ, Popma JJ, Muller DW, Burek KA, Topol EJ. In-hospital costs associated with new percutaneous coronary devices. Am J Cardiol. 1991 Oct 1;68(9):879-85. doi: 10.1016/0002-9149(91)90403-8.
PubMed 1927947Krause PB, Klein LW. Utility of a percutaneous collagen hemostasis device: to plug or not to plug? J Am Coll Cardiol. 1993 Nov 1;22(5):1280-2. doi: 10.1016/0735-1097(93)90530-e. No abstract available.
PubMed 8227780Anderson HV, Bertrand M, Whitworth HB, Sax FL, Willerson JT for the Restore Investigators. Bleeding risk with platelet inhibition using Tirofiban: The Restore Trial. Circulation. 94:I-553, 1996.
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Post-Market, Prospective, Multi-Center, Study to Evaluate Safety and Efficacy of the StarClose™ Vascular Closure System in Patients Who Are Ambulated Early Post-Diagnostic Catheterization
- ClinicalTrials.gov ID
- NCT00736086
- Acronym / sponsor ID
- AVD-640-0057
- Keywords
- femoral artery, post-percutaneous cardiac catheterization, post-percutaneous peripheral vascular catheterization, post-percutaneous diagnostic catheterization, early ambulation, vascular closure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- Mar 2006
- Primary completion
- Nov 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 15 Aug 2008 (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.
To evaluate early ambulation in patients who receive the StarClose™ VCS post-percutaneous diagnostic procedure.
Detailed description
To evaluate the StarClose™ VCS in the femoral artery in subjects who are ambulated early post-percutaneous cardiac or peripheral vascular, diagnostic catheterization procedure. The clinical use of vascular closure devices for rapid hemostasis after femoral access was first reported in 1991. 18 participants may be ambulated almost immediately after diagnostic coronary angiography and discharged many hours earlier than currently practiced in most centers utilizing a supine restriction period of 6 hours after diagnostic catheterization.14 After coronary interventions, participant comfort is additionally increased by immediate sheath removal.
This early ambulation study is an evaluation of a clip-based technology, which achieves vascular hemostasis with the use of a novel extravascular Nitinol clip to provide an immediate mechanical closure that does not depend upon the body's clotting system. The procedures will be performed in participants who meet specific entrance criteria.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Vessel Closure (StarClose™)Subjects who are ambulated early post-percutaneous, cardiac or peripheral vascular, diagnostic catheterization procedures with the use of StarClose® Vascular Closure System in the femoral artery after diagnostic catheterization procedure. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who are ambulated early post-percutaneous, cardiac or peripheral vascular, diagnostic catheterization procedure
Key inclusion criteria (6 listed)
- Subject must be 18-85.
- Subject must be an acceptable candidate for an elective,non-emergent diagnostic procedure performed percutaneously via the common femoral artery through either a 5F or 6F procedural sheath.
- Subject is an acceptable candidate for emergent vascular surgery.
- Subject agrees to follow-up evaluations to assess for complications related to femoral access site.
- If among the 50 ultrasound sub-study Subjects enrolled,Subject agrees to have an ultrasound of femoral artery performed post-procedure during the 30 ± 7 days follow-up visit.
Key exclusion criteria (32 listed)
- History of bleeding diathesis or coagulopathy including hemophilia, von Willebrand's disease, and/or a current, known platelet count <100,000 cells/mm3, or baseline INR > 1.7.
- Body Mass Index (BMI) ³ 35 kg/m2.
- Presence of significant anemia (Hgb < 10 g/dL, Hct < 30%).
- Advanced Subject refusal of blood transfusions, should transfusion become necessary.
- Participation in another trial of an investigational drug or device that has not yet completed follow-up requirements.
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 |
|---|---|---|
| Vessel Closure (StarClose™) | Device | 1 |
Primary outcome
Not reported in the source record.
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 15 Aug 2008.
- Background: PubMed 8874942Krone RJ, Johnson L, Noto T. Five year trends in cardiac catheterization: a report from the Registry of the Society for Cardiac Angiography and Interventions. Cathet Cardiovasc Diagn. 1996 Sep;39(1):31-5. doi: 10.1002/ccd.1810390102.
- Background: PubMed 8644584Waksman R, Scott NA, Ghazzal ZM, Mays R, Frerichs FA, Petersen JY, King SB 3rd. Randomized comparison of flexible versus nonflexible femoral sheaths on patient comfort after angioplasty. Am Heart J. 1996 Jun;131(6):1076-8. doi: 10.1016/s0002-8703(96)90079-4.
- Background: PubMed 7728861Bogart DB, Bogart MA, Miller JT, Farrar MW, Barr WK, Montgomery MA. Femoral artery catheterization complications: a study of 503 consecutive patients. Cathet Cardiovasc Diagn. 1995 Jan;34(1):8-13. doi: 10.1002/ccd.1810340304.
- BackgroundChristensen B, Lacarella C, Manion R, Bruhn-Ding B, Meyer S, Wilson R. Sandbags do not prevent complications after catheterization. Circulation 90:I-205, 1994.
- Background: PubMed 9576155Pracyk JB, Wall TC, Longabaugh JP, Tice FD, Hochrein J, Green C, Cox G, Lee K, Stack RS, Tcheng JE. A randomized trial of vascular hemostasis techniques to reduce femoral vascular complications after coronary intervention. Am J Cardiol. 1998 Apr 15;81(8):970-6. doi: 10.1016/s0002-9149(98)00074-5.
- Background: PubMed 8498298Resar JR, Prewitt KC, Wolff MR, Blumenthal R, Raqueno JV, Brinker JA. Percutaneous transluminal coronary angioplasty through 6F diagnostic catheters: a feasibility study. Am Heart J. 1993 Jun;125(6):1591-6. doi: 10.1016/0002-8703(93)90745-u.
- Background: PubMed 1799761Cragg AH, Nakagawa N, Smith TP, Berbaum KS. Hematoma formation after diagnostic angiography: effect of catheter size. J Vasc Interv Radiol. 1991 May;2(2):231-3. doi: 10.1016/s1051-0443(91)72287-2.
- Background: PubMed 7732995Waksman R, King SB 3rd, Douglas JS, Shen Y, Ewing H, Mueller L, Ghazzal ZM, Weintraub WS. Predictors of groin complications after balloon and new-device coronary intervention. Am J Cardiol. 1995 May 1;75(14):886-9. doi: 10.1016/s0002-9149(99)80681-x.
- Background: PubMed 2912567Campeau L. Percutaneous radial artery approach for coronary angiography. Cathet Cardiovasc Diagn. 1989 Jan;16(1):3-7. doi: 10.1002/ccd.1810160103.
- Background: PubMed 9137223Kiemeneij F, Laarman GJ, Odekerken D, Slagboom T, van der Wieken R. A randomized comparison of percutaneous transluminal coronary angioplasty by the radial, brachial and femoral approaches: the access study. J Am Coll Cardiol. 1997 May;29(6):1269-75. doi: 10.1016/s0735-1097(97)00064-8.
- Background: PubMed 9778323Bertrand ME, Legrand V, Boland J, Fleck E, Bonnier J, Emmanuelson H, Vrolix M, Missault L, Chierchia S, Casaccia M, Niccoli L, Oto A, White C, Webb-Peploe M, Van Belle E, McFadden EP. Randomized multicenter comparison of conventional anticoagulation versus antiplatelet therapy in unplanned and elective coronary stenting. The full anticoagulation versus aspirin and ticlopidine (fantastic) study. Circulation. 1998 Oct 20;98(16):1597-603. doi: 10.1161/01.cir.98.16.1597.
- Background: PubMed 9834303Leon MB, Baim DS, Popma JJ, Gordon PC, Cutlip DE, Ho KK, Giambartolomei A, Diver DJ, Lasorda DM, Williams DO, Pocock SJ, Kuntz RE. A clinical trial comparing three antithrombotic-drug regimens after coronary-artery stenting. Stent Anticoagulation Restenosis Study Investigators. N Engl J Med. 1998 Dec 3;339(23):1665-71. doi: 10.1056/NEJM199812033392303.
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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.
William Kussmaul, MD principal investigator
Drexel University/Hahnemann
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Vascular Disease and Cardiovascular Disease, run by Abbott Medical Devices at 11 sites in United States.
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 6 inclusion and 32 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 15 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00736086, which also lists 28 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 15 Aug 2008.