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Percutaneous Coronary InterventionNCT02691819

Short Term and Long Term Effects of Single Stent and Embedded Balloon Angioplasty in the Treatment of Coronary Bifurcation Lesions

An observational study of Percutaneous Coronary Intervention, run by ZhangWenduo at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

At the same time in the side branch stent expansion vessels were embedded and balloon dilatation technique in for Medina1.1.1 type, 1.0.1 type or 0.1.1 type lesions of interventional therapy for bifurcation lesions, the PCI preoperative and postoperative 6 h, 24h of all patients were at least three times ECG and assay… Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Percutaneous Coronary Intervention
What is being tested?
single stent and embedded balloon angioplasty
Type of treatment
Medical device
How many people
60 participants
Where
1 siteChina
Study dates
Jan 2015to Jan 2015
How long will I take part?
9 Months
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: Baseline characteristics of the patients with screening and recorded by a case by coronary artery angiography of each coronary bifurcation lesions according to the Medina classification method to classify, only select the 1.1.1 type, type 1.0.1 or 0.1.1 type III lesions,.

Who may be able to join

  • Inclusion criteria: selected patients aged 18-80 years of intervention in patients. Baseline characteristics of the patients with screening and recorded by a case by coronary artery angiography of each coronary bifurcation lesions according to the Medina classification method to classify, only select the 1.1.1 type, type 1.0.1 or 0.1.1 type III lesions, a total of 80, respectively, of the type of bifurcation lesions, the random number method lesions were divided into according to the ratio of 1:3 established traditional surgical PCI group 20 lesions and a new operative method for 60 lesions group and interventional therapy. All patients who were involved in the treatment before treatment (sign) or their family members agreed to and signed informed consent. All patients were pre evaluated for long-term oral aspirin (100 mg/, once daily) and clopidogrel (75 mg/ times a day) for at least 1 years

Who cannot join

  • Be of aspirin or clopidogrel allergy or intolerance are; the illness history of stroke or visceral hemorrhage within six months; serious liver disease and (or) coagulation abnormality; with antiplatelet treatment contraindications or recently proposed surgical person; valvular heart disease, cardiomyopathy, myocarditis, congenital heart disease, peripheral vascular disease, infection endocarditis; late kidney function not whole, tumor and chronic heart failure seriously affect the short-term prognosis of disease.Patients unable to complete follow-up.

Trial locations and contacts

1 site in 1 country.

Zhang Wenduo, PHD contact

=8613911616799

drzhangwenduo@163.com

China1 site, 1 recruiting

  • Zhang Wenduo

    Beijing, Beijing Municipality, 100730

    Zhang Wenduo, PHD, +8613911616799, drzhangwenduo@163.com

    Recruiting

Other trials in China

About this study

At the same time in the side branch stent expansion vessels were embedded and balloon dilatation technique in for Medina1.1.1 type, 1.0.1 type or 0.1.1 type lesions of interventional therapy for bifurcation lesions, the PCI preoperative and postoperative 6 h, 24h of all patients were at least three times ECG and assay of creatine kinase isoenzyme (CK-MB) and cardiac troponin T (TNT data analysis); immediately after operation and nine months after surgery, coronary angiography, quantitative coronary angiography, evaluation of each main branch and side branch of the lesion degree of stenosis (determination of bifurcation angle, reference vessel diameter, vessel diameter, minimum) and TIMI flow grade; using 256 slice spiral CT scanner to scan each main branch lesion and evaluation a side branch stenosis (determination of bifurcation angle, reference vessel diameter, vessel diameter, minimum). All patients were followed up for 1 months, 6 months, and 9 months follow-up. Cardiovascular events included total cause of death, cardiac death, total re hospitalization rate, recurrent myocardial infarction or unstable angina.

Being tested
single stent and embedded balloon angioplasty
Keywords
jailed-balloon technique

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • single stent and embedded balloon angioplastyDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MACE

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2016 (estimated)
  2. Study startJan 2015
  3. Primary completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
60 participants (estimated)
Target duration
9 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT02691819
Sponsor's protocol ID
BeijingHZWD001
Status last verified
Jan 2016
First submitted
22 Feb 2016
Last updated
25 Feb 2016
Results posted
No

Publications

  • Sharma SK, Sweeny J, Kini AS. Coronary bifurcation lesions: a current update. Cardiol Clin. 2010 Feb;28(1):55-70. doi: 10.1016/j.ccl.2009.10.001.

    PubMed 19962049

  • Murasato Y, Hikichi Y, Nakamura S, Kajiya F, Iwasaki K, Kinoshita Y, Yamawaki M, Shinke T, Yamada S, Yamashita T, Choo GH, Nam CW, Kim YH, Jepson N, Ferenc M. Recent perspective on coronary bifurcation intervention: statement of the "Bifurcation Club in KOKURA". J Interv Cardiol. 2010 Aug;23(4):295-304. doi: 10.1111/j.1540-8183.2010.00570.x.

    PubMed 20718905

  • Stankovic G, Lefevre T, Chieffo A, Hildick-Smith D, Lassen JF, Pan M, Darremont O, Albiero R, Ferenc M, Finet G, Adriaenssens T, Koo BK, Burzotta F, Louvard Y; European Bifurcation Club. Consensus from the 7th European Bifurcation Club meeting. EuroIntervention. 2013 May 20;9(1):36-45. doi: 10.4244/EIJV9I1A7. No abstract available.

    PubMed 23552575

  • von Korn H, Stefan V, van Ewijk R, Chakraborty K, Sanwald B, Andel R, Hemker J, Hink U, Ohlow M, Lauer B, Muenzel T. Treatment of coronary bifurcation lesions: stent-covering of the side branch with and without PCI of the side branch: a retrospective analysis of all consecutive patients. BMC Cardiovasc Disord. 2013 Apr 4;13:27. doi: 10.1186/1471-2261-13-27.

    PubMed 23557395

  • Poorhosseini HR, Kassaian SE, Hosseini SK, Fotoohi M, Salarifar M, Alidoosti M, Sharafi A, Nozari Y, Nematipour E, Aghajani H, Haji Zeinali AM, Amirzadegan A, Babapour B, Seyed Mohammad Zadeh MH. Impact of side-branch flow in coronary bifurcation intervention. J Tehran Heart Cent. 2012 Aug;7(3):100-5. Epub 2012 Aug 31.

    PubMed 23304177

  • Maeng M, Holm NR, Erglis A, Kumsars I, Niemela M, Kervinen K, Jensen JS, Galloe A, Steigen TK, Wiseth R, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Nikus K, Vikman S, Ravkilde J, James S, Aaroe J, Ylitalo A, Helqvist S, Sjogren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Christiansen EH, Lassen JF, Thuesen L; Nordic-Baltic Percutaneous Coronary Intervention Study Group. Long-term results after simple versus complex stenting of coronary artery bifurcation lesions: Nordic Bifurcation Study 5-year follow-up results. J Am Coll Cardiol. 2013 Jul 2;62(1):30-4. doi: 10.1016/j.jacc.2013.04.015. Epub 2013 May 1.

    PubMed 23644088

  • Kang SJ, Kim WJ, Lee JY, Park DW, Lee SW, Kim YH, Lee CW, Mintz GS, Park SW, Park SJ. Hemodynamic impact of changes in bifurcation geometry after single-stent cross-over technique assessed by intravascular ultrasound and fractional flow reserve. Catheter Cardiovasc Interv. 2013 Dec 1;82(7):1075-82. doi: 10.1002/ccd.24956. Epub 2013 Aug 1.

    PubMed 23592548

  • Steigen TK, Maeng M, Wiseth R, Erglis A, Kumsars I, Narbute I, Gunnes P, Mannsverk J, Meyerdierks O, Rotevatn S, Niemela M, Kervinen K, Jensen JS, Galloe A, Nikus K, Vikman S, Ravkilde J, James S, Aaroe J, Ylitalo A, Helqvist S, Sjogren I, Thayssen P, Virtanen K, Puhakka M, Airaksinen J, Lassen JF, Thuesen L; Nordic PCI Study Group. Randomized study on simple versus complex stenting of coronary artery bifurcation lesions: the Nordic bifurcation study. Circulation. 2006 Oct 31;114(18):1955-61. doi: 10.1161/CIRCULATIONAHA.106.664920. Epub 2006 Oct 23.

    PubMed 17060387

  • Hildick-Smith D, Lassen JF, Albiero R, Lefevre T, Darremont O, Pan M, Ferenc M, Stankovic G, Louvard Y; European Bifurcation Club. Consensus from the 5th European Bifurcation Club meeting. EuroIntervention. 2010 May;6(1):34-8. No abstract available.

    PubMed 20542795

Questions about this trial

What is this clinical trial studying?

An observational study of Percutaneous Coronary Intervention, run by ZhangWenduo at 1 site in China.

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 1 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 25 Feb 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 China. 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?

Contact Zhang Wenduo, PHD (=8613911616799, drzhangwenduo@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MACE (time frame: 9 months). 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 NCT02691819, which also lists 9 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 25 Feb 2016.

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