Comparative Study Between Intravascular Ultrasonography Guided and Angiography-guided Recanalization of Coronary Chronic Total Occlusions

NCT ID: NCT03159650

Last Updated: 2017-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2019-10-01

Brief Summary

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Chronic total occlusion is defined as thrombolysis in myocardial infarction (TIMI) flow grade 0 with an estimated duration of at least 3 months. The interest in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has increased, but with failure rate up to 20%, leading to important developments in dedicated equipment and techniques.

In the 2014 European Guidelines on Myocardial Revascularization, intravascular ultrasound was recommended to guide stent implantation in selected patients, and this recommendation was a class IIa/level of evidence B.

In CTO PCI, certain angiographic features such as blunt proximal CTO cap, tortuosity, heavy calcification, and lack of visibility of path in the distal vessel increase procedural difficulty

Detailed Description

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Conditions

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Coronary Occlusion

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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intravascular ultrasonography guided

Group Type EXPERIMENTAL

intravascular ultrasonography

Intervention Type DEVICE

intravascular ultrasonography will be used during the study for the resolving proximal cap ambiguity of chronic total occlusion, facilitating re-entry into the true lumen after subintimal crossing and confirming distal true lumen guidewire position

Angiography guided

Group Type ACTIVE_COMPARATOR

intravascular ultrasonography

Intervention Type DEVICE

intravascular ultrasonography will be used during the study for the resolving proximal cap ambiguity of chronic total occlusion, facilitating re-entry into the true lumen after subintimal crossing and confirming distal true lumen guidewire position

Interventions

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intravascular ultrasonography

intravascular ultrasonography will be used during the study for the resolving proximal cap ambiguity of chronic total occlusion, facilitating re-entry into the true lumen after subintimal crossing and confirming distal true lumen guidewire position

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients with coronary angiography showing chronic coronary total

Exclusion Criteria

1. Acute coronary syndrome within 3 months.
2. Patients with previous coronary artery bypass graft (CABG).
3. Patients with known renal insufficiency (eGFR \< 60 ml/kg/m2, serum creatinine ≥ 2.5 mg/dL, or on dialysis).
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Osman Abdelhamead

Assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Hosam Hasan, professor

Role: CONTACT

+20882361015

Mohamed karim, assistant professor

Role: CONTACT

+201119340685

References

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Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Juni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Uva MS, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A; Grupa Robocza Europejskiego Towarzystwa Kardiologicznego (ESC); Europejskie Stowarzyszenie Chirurgii Serca i Klatki Piersiowej (EACTS) do spraw rewaskularyzacji miesnia sercowego; European Association for Percutaneous Cardiovascular Interventions (EAPCI). [2014 ESC/EACTS Guidelines on myocardial revascularization]. Kardiol Pol. 2014;72(12):1253-379. doi: 10.5603/KP.2014.0224. No abstract available. Polish.

Reference Type BACKGROUND
PMID: 25524605 (View on PubMed)

Park Y, Park HS, Jang GL, Lee DY, Lee H, Lee JH, Kang HJ, Yang DH, Cho Y, Chae SC, Jun JE, Park WH. Intravascular ultrasound guided recanalization of stumpless chronic total occlusion. Int J Cardiol. 2011 Apr 14;148(2):174-8. doi: 10.1016/j.ijcard.2009.10.052. Epub 2009 Nov 26.

Reference Type BACKGROUND
PMID: 19942305 (View on PubMed)

Stone GW, Reifart NJ, Moussa I, Hoye A, Cox DA, Colombo A, Baim DS, Teirstein PS, Strauss BH, Selmon M, Mintz GS, Katoh O, Mitsudo K, Suzuki T, Tamai H, Grube E, Cannon LA, Kandzari DE, Reisman M, Schwartz RS, Bailey S, Dangas G, Mehran R, Abizaid A, Moses JW, Leon MB, Serruys PW. Percutaneous recanalization of chronically occluded coronary arteries: a consensus document: part II. Circulation. 2005 Oct 18;112(16):2530-7. doi: 10.1161/CIRCULATIONAHA.105.583716. No abstract available.

Reference Type BACKGROUND
PMID: 16230504 (View on PubMed)

Other Identifiers

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IVUSAN

Identifier Type: -

Identifier Source: org_study_id

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