Coronary Artery DiseasePhase 4NCT02954029
Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures
A Phase 4 study testing ezClot (hemostasis pad), BloodSTOP ix pad and Rotary compression device in people with Coronary Artery Disease and Puncture, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
Arterial access is the key step during the endovascular treatment of cardiovascular diseases. This study was designed to confirm the safety and efficacy of the hemostasis pad using chitosan in patients undergoing percutaneous procedures with arterial approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, Puncture
- What is being tested?
- ezClot (hemostasis pad), BloodSTOP ix pad and Rotary compression device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 315 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2016to Dec 2017
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 years or older
- patients undergoing invasive procedures via the radial or femoral arteries
Who cannot join
- congenital or acquired bleeding tendency
- platelet count <50,000/ μL
- hypersensitivity to shrimps, lobsters or beetles
Trial locations and contacts
1 site in 1 country.
In-Ho Chae contact
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 06511
In-Ho Chae, ihchae@snubh.org
Si-Hyuck Kang, 82-10-4011-5801, eandp303@snu.ac.kr
About this study
Arterial access is the key step during the endovascular treatment of cardiovascular diseases. This study was designed to confirm the safety and efficacy of the hemostasis pad using chitosan in patients undergoing percutaneous procedures with arterial approach. Two cohorts will be included in this study: transradial and transfemoral cohort. Among the transfemoral cohort, the safety and efficacy of the ezClot pad will be compared with the BloodSTOP® pad (LifeScience PLUS, Palo Alto, CA, USA). The BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway. The hypothesis will be tested among the transradial cohort that the combined use of a hemostasis pad and a compression device is superior to that of a compression device only in terms of hemostasis in patients who underwent tranradial coronary procedures.
Read the detailed description
Arterial access is the key step during the endovascular treatment of cardiovascular diseases. However, failure in hemostasis of the arterial access sites is associated with high risk of complications such as bleeding, pseudoaneurysm, and arteriovenous fistula. Major bleeding events after percutaneous coronary intervention has been shown be associated with poor short-term as well as long-term prognosis. Thus, there have been a variety of approaches to quickly and effectively achieve hemostasis of the puncture site. The traditional method was to apply manual compression followed by simple dressing directly on the puncture site. Despite a long history and economic advantage, this method required prolonged hemostasis time, substantial efforts by trained practitioner, and patients' discomfort.
Use of hemostasis pad that accelerates blood clotting has become an effective alternative. The ezClot pad is a new product that uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin. The positively charged chitosan molecules attract the negatively charged blood cells and platelets, thus promoting clots. The ability to hemostasis of chitosan has been proven with the HemCon® pad (HemCon Medical Technologies, Inc., Portland, OR, USA). This study was designed to confirm the safety and efficacy of the ezClot pad in patients undergoing percutaneous procedures with arterial approach. Two cohorts will be included in this study: transradial and transfemoral cohort. Among the transfemoral cohort, the safety and efficacy of the ezClot pad will be compared with the BloodSTOP® pad (LifeScience PLUS, Palo Alto, CA, USA). The BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway.
Transradial approach is increasing used during coronary procedures. The most important benefit of transradial approach compared to transfemoral approach is low risk of major bleeding. Widely used method for hemostasis of radial puncture sites were manual or device-assisted compression. There is yet only a limited data regarding the use of hemostasis pad after transradial approach. The hypothesis will be tested in the transradial cohort that the combined use of a hemostasis pad and a compression device is superior to that of a compression device only in terms of hemostasis in patients who underwent transradial coronary procedures.
- Conditions
- Coronary Artery Disease, Puncture
- Being tested
- ezClot (hemostasis pad), BloodSTOP ix pad, Rotary compression device
- 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.
ezClot (hemostasis pad)Device
ezClot pad uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin, to accelerate blood clotting.
BloodSTOP ix padDevice
BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway.
Rotary compression deviceDevice
Rotary compression device consists of a plastic arch and a rotary screw to deliver local pressure by moving the silicone compression pad.
| Study group | Role | What they receive |
|---|---|---|
| Study group (transradial cohort) | Experimental | device-assisted compression with ezClot pad Receives: Device: ezClot (hemostasis pad); Device: Rotary compression device |
| Study group (transfemoral cohort) | Experimental | manual compression with ezClot pad Receives: Device: ezClot (hemostasis pad) |
| Control group (transradial cohort) | Active comparator | Rotary compression device Receives: Device: Rotary compression device |
| Control group (transfemoral cohort) | Active comparator | manual compression with BloodSTOP ix pad Receives: Device: BloodSTOP ix pad |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to hemostasis
Measured: Immediately after invasive procedures
Secondary outcomes (8)
Bleeding
TIMI major/minor bleeding within 24 hours
Measured: within 24 hours
Hematoma
Hematoma within 24 hours
Measured: within 24 hours
Retroperitoneal hematoma
Retroperitoneal hematoma within 24 hours
Measured: within 24 hours
Pseudoaneurysm
Pseudoaneurysm within 24 hours
Measured: within 24 hours
Vessel occlusion
Vessel occlusion within 24 hours (either 1 or 2)
- no palpable pulse
- no flow on Doppler
Measured: within 24 hours
Dissection
Dissection of access vessel within 24 hours (either 1 or 2)
- observed on angiography
- symptomatic compromising distal flow
Measured: within 24 hours
Surgical repair
Surgical repair within 24 hours
Measured: within 24 hours
Vasovagal reaction
Vasovagal reaction (grade 3-4) within 24 hours
Measured: within 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2016 (estimated)
- Study startApr 2016
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 315 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Si-Hyuck Kang, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02954029
- Sponsor's protocol ID
- ezClot1
- Status last verified
- Nov 2016
- First submitted
- 12 Jul 2016
- Last updated
- 3 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Suh JW, Mehran R, Claessen BE, Xu K, Baber U, Dangas G, Parise H, Lansky AJ, Witzenbichler B, Grines CL, Guagliumi G, Kornowski R, Wohrle J, Dudek D, Weisz G, Stone GW. Impact of in-hospital major bleeding on late clinical outcomes after primary percutaneous coronary intervention in acute myocardial infarction the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2011 Oct 18;58(17):1750-6. doi: 10.1016/j.jacc.2011.07.021.
PubMed 21996385Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation. 2006 Aug 22;114(8):774-82. doi: 10.1161/CIRCULATIONAHA.106.612812. Epub 2006 Aug 14.
PubMed 16908769Pusateri AE, Holcomb JB, Kheirabadi BS, Alam HB, Wade CE, Ryan KL. Making sense of the preclinical literature on advanced hemostatic products. J Trauma. 2006 Mar;60(3):674-82. doi: 10.1097/01.ta.0000196672.47783.fd.
PubMed 16531876Arbel J, Rozenbaum E, Reges O, Neuman Y, Levi A, Erel J, Haskia AR, Caneti M, Sherf M, Mosseri M. USage of chitosan for Femoral (USF) haemostasis after percutaneous procedures: a comparative open label study. EuroIntervention. 2011 Apr;6(9):1104-9. doi: 10.4244/EIJV6I9A192.
PubMed 21518684Ferretti L, Qiu X, Villalta J, Lin G. Efficacy of BloodSTOP iX, surgicel, and gelfoam in rat models of active bleeding from partial nephrectomy and aortic needle injury. Urology. 2012 Nov;80(5):1161.e1-6. doi: 10.1016/j.urology.2012.06.048. Epub 2012 Aug 22.
PubMed 22921708Rathore S, Stables RH, Pauriah M, Hakeem A, Mills JD, Palmer ND, Perry RA, Morris JL. A randomized comparison of TR band and radistop hemostatic compression devices after transradial coronary intervention. Catheter Cardiovasc Interv. 2010 Nov 1;76(5):660-7. doi: 10.1002/ccd.22615.
PubMed 20506228Cong X, Huang Z, Wu J, Wang J, Wen F, Fang L, Fan M, Liang C. Randomized Comparison of 3 Hemostasis Techniques After Transradial Coronary Intervention. J Cardiovasc Nurs. 2016 Sep-Oct;31(5):445-51. doi: 10.1097/JCN.0000000000000268.
PubMed 26002786Dai N, Xu DC, Hou L, Peng WH, Wei YD, Xu YW. A comparison of 2 devices for radial artery hemostasis after transradial coronary intervention. J Cardiovasc Nurs. 2015 May-Jun;30(3):192-6. doi: 10.1097/JCN.0000000000000115.
PubMed 24496325Choi EY, Ko YG, Kim JB, Rhee J, Park S, Choi D, Jang Y, Shim WH, Cho SY. Hemostatic efficacy of hydrophilic wound dressing after transradial catheterization. J Invasive Cardiol. 2005 Sep;17(9):459-62.
PubMed 16145231Kang SH, Han D, Kim S, Yoon CH, Park JJ, Suh JW, Cho YS, Youn TJ, Chae IH. Hemostasis pad combined with compression device after transradial coronary procedures: A randomized controlled trial. PLoS One. 2017 Jul 24;12(7):e0181099. doi: 10.1371/journal.pone.0181099. eCollection 2017.
PubMed 28742134
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostasis Pad Using Chitosan After Invasive Percutaneous Procedures
- ClinicalTrials.gov ID
- NCT02954029
- Acronym / sponsor ID
- ezClot1
- Conditions
- Coronary Artery Disease, Puncture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 3 Nov 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.
Arterial access is the key step during the endovascular treatment of cardiovascular diseases. This study was designed to confirm the safety and efficacy of the hemostasis pad using chitosan in patients undergoing percutaneous procedures with arterial approach. Two cohorts will be included in this study: transradial and transfemoral cohort. Among the transfemoral cohort, the safety and efficacy of the ezClot pad will be compared with the BloodSTOP® pad (LifeScience PLUS, Palo Alto, CA, USA). The BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway. The hypothesis will be tested among the transradial cohort that the combined use of a hemostasis pad and a compression device is superior to that of a compression device only in terms of hemostasis in patients who underwent tranradial coronary procedures.
Detailed description
Arterial access is the key step during the endovascular treatment of cardiovascular diseases. However, failure in hemostasis of the arterial access sites is associated with high risk of complications such as bleeding, pseudoaneurysm, and arteriovenous fistula. Major bleeding events after percutaneous coronary intervention has been shown be associated with poor short-term as well as long-term prognosis. Thus, there have been a variety of approaches to quickly and effectively achieve hemostasis of the puncture site. The traditional method was to apply manual compression followed by simple dressing directly on the puncture site. Despite a long history and economic advantage, this method required prolonged hemostasis time, substantial efforts by trained practitioner, and patients' discomfort.
Use of hemostasis pad that accelerates blood clotting has become an effective alternative. The ezClot pad is a new product that uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin. The positively charged chitosan molecules attract the negatively charged blood cells and platelets, thus promoting clots. The ability to hemostasis of chitosan has been proven with the HemCon® pad (HemCon Medical Technologies, Inc., Portland, OR, USA). This study was designed to confirm the safety and efficacy of the ezClot pad in patients undergoing percutaneous procedures with arterial approach. Two cohorts will be included in this study: transradial and transfemoral cohort. Among the transfemoral cohort, the safety and efficacy of the ezClot pad will be compared with the BloodSTOP® pad (LifeScience PLUS, Palo Alto, CA, USA). The BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway.
Transradial approach is increasing used during coronary procedures. The most important benefit of transradial approach compared to transfemoral approach is low risk of major bleeding. Widely used method for hemostasis of radial puncture sites were manual or device-assisted compression. There is yet only a limited data regarding the use of hemostasis pad after transradial approach. The hypothesis will be tested in the transradial cohort that the combined use of a hemostasis pad and a compression device is superior to that of a compression device only in terms of hemostasis in patients who underwent transradial coronary procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Study group (transradial cohort) | Experimental | Device: ezClot (hemostasis pad), Device: Rotary compression devicedevice-assisted compression with ezClot pad |
| Study group (transfemoral cohort) | Experimental | Device: ezClot (hemostasis pad)manual compression with ezClot pad |
| Control group (transradial cohort) | Active comparator | Device: Rotary compression deviceRotary compression device |
| Control group (transfemoral cohort) | Active comparator | Device: BloodSTOP ix padmanual compression with BloodSTOP ix pad |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age 18 years or older
- patients undergoing invasive procedures via the radial or femoral arteries
Key exclusion criteria (3 listed)
- congenital or acquired bleeding tendency
- platelet count <50,000/ μL
- hypersensitivity to shrimps, lobsters or beetles
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 |
|---|---|---|
| ezClot (hemostasis pad)ezClot pad uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin, to accelerate blood clotting. | Device | Study group (transfemoral cohort), Study group (transradial cohort) |
| BloodSTOP ix padBloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway. | Device | Control group (transfemoral cohort) |
| Rotary compression deviceRotary compression device consists of a plastic arch and a rotary screw to deliver local pressure by moving the silicone compression pad. | Device | Control group (transradial cohort), Study group (transradial cohort) |
Primary outcome
Time to hemostasis
Time frame: Immediately after invasive procedures
8 secondary outcomes
Bleeding
Time frame: within 24 hours
Hematoma
Time frame: within 24 hours
Retroperitoneal hematoma
Time frame: within 24 hours
Pseudoaneurysm
Time frame: within 24 hours
Vessel occlusion
Time frame: within 24 hours
Dissection
Time frame: within 24 hours
Surgical repair
Time frame: within 24 hours
Vasovagal reaction
Time frame: within 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2016.
- Background: PubMed 21996385Suh JW, Mehran R, Claessen BE, Xu K, Baber U, Dangas G, Parise H, Lansky AJ, Witzenbichler B, Grines CL, Guagliumi G, Kornowski R, Wohrle J, Dudek D, Weisz G, Stone GW. Impact of in-hospital major bleeding on late clinical outcomes after primary percutaneous coronary intervention in acute myocardial infarction the HORIZONS-AMI (Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction) trial. J Am Coll Cardiol. 2011 Oct 18;58(17):1750-6. doi: 10.1016/j.jacc.2011.07.021.
- Background: PubMed 16908769Eikelboom JW, Mehta SR, Anand SS, Xie C, Fox KA, Yusuf S. Adverse impact of bleeding on prognosis in patients with acute coronary syndromes. Circulation. 2006 Aug 22;114(8):774-82. doi: 10.1161/CIRCULATIONAHA.106.612812. Epub 2006 Aug 14.
- Background: PubMed 16531876Pusateri AE, Holcomb JB, Kheirabadi BS, Alam HB, Wade CE, Ryan KL. Making sense of the preclinical literature on advanced hemostatic products. J Trauma. 2006 Mar;60(3):674-82. doi: 10.1097/01.ta.0000196672.47783.fd.
- Background: PubMed 21518684Arbel J, Rozenbaum E, Reges O, Neuman Y, Levi A, Erel J, Haskia AR, Caneti M, Sherf M, Mosseri M. USage of chitosan for Femoral (USF) haemostasis after percutaneous procedures: a comparative open label study. EuroIntervention. 2011 Apr;6(9):1104-9. doi: 10.4244/EIJV6I9A192.
- Background: PubMed 22921708Ferretti L, Qiu X, Villalta J, Lin G. Efficacy of BloodSTOP iX, surgicel, and gelfoam in rat models of active bleeding from partial nephrectomy and aortic needle injury. Urology. 2012 Nov;80(5):1161.e1-6. doi: 10.1016/j.urology.2012.06.048. Epub 2012 Aug 22.
- Background: PubMed 20506228Rathore S, Stables RH, Pauriah M, Hakeem A, Mills JD, Palmer ND, Perry RA, Morris JL. A randomized comparison of TR band and radistop hemostatic compression devices after transradial coronary intervention. Catheter Cardiovasc Interv. 2010 Nov 1;76(5):660-7. doi: 10.1002/ccd.22615.
- Background: PubMed 26002786Cong X, Huang Z, Wu J, Wang J, Wen F, Fang L, Fan M, Liang C. Randomized Comparison of 3 Hemostasis Techniques After Transradial Coronary Intervention. J Cardiovasc Nurs. 2016 Sep-Oct;31(5):445-51. doi: 10.1097/JCN.0000000000000268.
- Background: PubMed 24496325Dai N, Xu DC, Hou L, Peng WH, Wei YD, Xu YW. A comparison of 2 devices for radial artery hemostasis after transradial coronary intervention. J Cardiovasc Nurs. 2015 May-Jun;30(3):192-6. doi: 10.1097/JCN.0000000000000115.
- Background: PubMed 16145231Choi EY, Ko YG, Kim JB, Rhee J, Park S, Choi D, Jang Y, Shim WH, Cho SY. Hemostatic efficacy of hydrophilic wound dressing after transradial catheterization. J Invasive Cardiol. 2005 Sep;17(9):459-62.
- Derived from this study: PubMed 28742134Kang SH, Han D, Kim S, Yoon CH, Park JJ, Suh JW, Cho YS, Youn TJ, Chae IH. Hemostasis pad combined with compression device after transradial coronary procedures: A randomized controlled trial. PLoS One. 2017 Jul 24;12(7):e0181099. doi: 10.1371/journal.pone.0181099. eCollection 2017.
- Individual participant dataSharing planned: No
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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.
In-Ho Chae contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ezClot (hemostasis pad), BloodSTOP ix pad and Rotary compression device in people with Coronary Artery Disease and Puncture, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 2 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: status not confirmed, as of the sponsor's last update on 3 Nov 2016. 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 South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact In-Ho Chae (ihchae@snubh.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to hemostasis (time frame: Immediately after invasive procedures). 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 NCT02954029, which also lists 10 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 3 Nov 2016.