Coronary Microcirculatory and Bioresorbable Vascular Scaffolds

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

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-01

Study Completion Date

2021-03-10

Brief Summary

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Angina and heart attacks are caused by narrowings in the coronary arteries (blood vessels) supplying the heart. These narrowings can be opened using a balloon and stent (angioplasty). Traditionally, stents are constructed from metal and are permanent. However, newer stents are being constructed from carbohydrate polymers (scaffolds), which allow them to reabsorb over time leaving no permanent implant. New data has suggested that these scaffolds appear to reduce recurrent angina and may alter the blood flow down the artery. However, it is not known whether this is due to the scaffolds themselves or the way the scaffolds are inserted. In this study we hope to measure the blood flow to the heart and assess changes in that flow during stent and scaffold insertion. It is also important to know whether these effects are durable and thus, a cohort of patients will return at 3-months to be restudied. These data are important to help us understand why blood flow is affected by stent/scaffold selection or device implantation technique and whether this results in better long-term outcomes.

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Detailed Description

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Conditions

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CHD - Coronary Heart Disease Angina, Stable Myocardial Ischemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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DES-std group

(DES: drug-eluting stent). Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.

Group Type ACTIVE_COMPARATOR

Drug-Eluting Stent (DES) - standard(std)

Intervention Type DEVICE

Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.

DES-slow group

(DES: drug-eluting stent). Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage.

After the interim analysis DES-slow to be compared with BVS.

Group Type EXPERIMENTAL

Drug-Eluting Stent (DES) - slow

Intervention Type DEVICE

Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage.

After the interim analysis DES-slow to be compared with BVS.

BVS group

(Bioresorbable Vascular Scaffold) Introduced after the interim analysis (phase 2) for comparison with DES-slow.

Group Type EXPERIMENTAL

Bioresorbable Vascular Scaffolds (BVS)

Intervention Type DEVICE

Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.

Interventions

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Bioresorbable Vascular Scaffolds (BVS)

Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.

Intervention Type DEVICE

Drug-Eluting Stent (DES) - slow

Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage.

After the interim analysis DES-slow to be compared with BVS.

Intervention Type DEVICE

Drug-Eluting Stent (DES) - standard(std)

Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.

Intervention Type DEVICE

Other Intervention Names

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ABSORB Xience Xience

Eligibility Criteria

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Inclusion Criteria

1. Patient age \>18 years, \<75 years.
2. Lesion suitability for BVS deployment: target vessel calibre \>2.3mm and \<3.8mm reference diameter, without significant tortuosity or calcification.
3. Listed for single-vessel PCI procedure.
4. Lesion length≤28mm (to accommodate single BVS/DES)
5. Preserved left ventricular ejection fraction (EF≥50%).

Exclusion Criteria

1. Patients with confirmed myocardial infarction within the preceding 2 months.
2. Allergy or intolerance to aspirin, clopidogrel, prasugrel or ticagrelor or contraindication to 12 months' dual antiplatelet therapy.
3. Contraindication to use of adenosine (asthma/chronic lung disease with documented bronchoreactivity).
4. Significant known comorbidity or terminal condition with life expectancy \<6 months.
5. Pregnancy.
6. Coagulopathy or warfarin treatment.
7. Significant renal impairment (baseline creatinine\>130 mmol/l).
8. Other comorbid condition that may affect microcirculatory function or troponin release (eg. Seropositive inflammatory conditions).
9. Inability to comply with follow-up requirements.
10. Target lesion in left mainstem, saphenous vein or arterial grafts.
11. Chronic total occlusion.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No