Health TrialsbyHealthPanel

Efficacy of the COronary SInus Reducer in Patients With Refractory Angina II

ConditionRefractory Angina
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorShockwave Medical, Inc.

About this trial

To demonstrate the safety and effectiveness of the Shockwave Reducer for treatment of patients with refractory angina pectoris treated with maximally tolerated guideline-directed medical therapy who demonstrate objective evidence of reversible myocardial ischemia in the distribution of the left coronary artery and who are deemed unsuitable for revascularization. A non-randomized single-arm registry will further assess the safety and effectiveness of the Shockwave Reducer in selected subjects with reversible myocardial ischemia in the distribution of the right coronary artery and who are deemed unsuitable for revascularization, subjects without documented obstructive coronary disease and abnormal coronary flow reserve (ANOCA), and subjects who cannot complete an exercise tolerance test due to lower limb amputation (above the ankle) or other physiologic condition with documented chronic mobility or balance issues that require the use of a walking aid.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subject is older than 18 years of age

Symptomatic coronary artery disease (CAD) with greater than or equal to 90 days of persistent refractory angina pectoris classified as CCS Grade III or IV despite maximally tolerated guideline directed medical therapy as determined by the local heart team and confirmed by a Central Screening Eligibility Committee Note: subjects may also have exertional dyspnea, but the symptoms that limit activity must be anginal in nature (including chest pain, pressure, heaviness, discomfort, with or without radiation to the neck, jaw, shoulders, arms, or other location) and not dyspnea

Must have attempted treatment with the maximally tolerated dose of at least three of the four (preferably all four) approved classes of anti-anginal agents: long-acting nitrates, calcium channel blockers (either a dihydropyridine or a non-dihydropyridine), beta blockers, and ranolazine. The regimen must be stable for at least 30 days prior to enrollment, must remain stable from enrollment to randomization, and there must be no intent to change the medical regimen for at least 12 months after randomization Note: If the dose of a medication was increased or decreased for a temporary period and then returned to the original dose, which will then be continued for at least 12 months after randomization, the subject may be immediately enrolled without needing to otherwise requalify

Subject has either no treatment options for revascularization by coronary artery bypass grafting or by percutaneous coronary intervention, or is otherwise unsuitable or high risk for revascularization as determined by the local heart team, and confirmed by a Central Screening Eligibility Committee

Disqualifiers

Recent (within 30 days prior to enrollment) troponin or CKMB positive acute coronary syndrome (NSTEMI or STEMI) Note: subjects with an elevated troponin or CKMB without acute coronary syndrome may still be enrolled

Recent successful revascularization by either CABG or PCI within six months prior to enrollment

Recent unsuccessful PCI (e.g., failed attempt to open a chronic total occlusion) within 30 days prior to enrollment

The predominant manifestation of angina is dyspnea

Trial design

Design model

Parallel

Treatments tested in this trial

  • Arm 1: treatment with Shockwave Reducer

    Device

    Shockwave reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms

  • Arm 2 (control): Implantation procedure with no device implanted

    Other intervention

    No device is implanted

  • Arm 3 (unblinded, non-randomized): Single arm registry

    Device

    Shockwave Reducer is an implantable device being evaluated for the alleviation of refractory angina symptoms

Treatment groups

380 Participants
are divided into 3 treatment groups
Group A: Arm 1 (treatment arm):Implantation of the Reducer deviceExperimental treatment 1 intervention
Group B: Arm 2 (sham-control arm): Control (no device implantation)Sham comparator 1 intervention
Group C: Arm 3 (unblinded, non-randomized): Single Arm RegistryOther 1 intervention

Trial outcomes

Primary outcomes

1

Co-Primary Effectiveness Endpoints

Change in total exercise duration in a modified Bruce treadmill exercise tolerance testing evaluation in the Treatment arm compared to Sham-control arm. Change in SAQ clinical summary score assessed at 6 months post procedure compared to baseline in the Treatment arm compared to the Sham-control arm.

Time frame
6 months
2

Primary Safety Endpoints

The rate of occurrence of a composite of death, myocardial infarction (MI), pericardial effusion requiring surgical or percutaneous intervention, device embolization, or BARC 3 or 5 bleeding evaluation in the Treatment arm compared to the Sham-control arm.

Time frame
6 months

Secondary outcomes

1

Canadian Cardiovascular Society (CCS) Angina Score

Improvement by greater than or equal to 1 CCS angina grade. The CCS grading system for angina is a clinical tool used by doctors to assess the degree of severity of a patient's angina. Possible scores range from Class 0 (asymptomatic angina) to Class IV (angina at rest).

Time frame
6 months
2

Canadian Cardiovascular Society (CCS) Angina Score

Improvement by greater than or equal to 2 CCS angina grades. The CCS grading system for angina is a clinical tool used by doctors to assess the degree of severity of a patient's angina. Possible scores range from Class 0 (asymptomatic angina) to Class IV (angina at rest).

Time frame
6 months

Other outcomes

1

Canadian Cardiovascular Society (CCS) Angina Score

Improvement by greater than or equal to 1 and greater than or equal to 2 CCS angina grades compared to baseline. The CCS grading system for angina is a clinical tool used by doctors to assess the degree of severity of a patient's angina. Possible scores range from Class 0 (asymptomatic angina) to Class IV (angina at rest).

Time frame
12 months, 2 years, 3 years, 4 years, and 5 years
2

Angina Burden

Angina frequency and burden compared to baseline

Time frame
6 and 12 months
3

Activity

Measure of activity assessed by actigraphy compared to baseline

Time frame
6 and 12 months
4

Exercise Tolerance Testing

Change in ETT parameters compared to baseline

Time frame
6 and 12 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shockwave Medical, Inc.

Lead sponsor

Source ClinicalTrials.gov
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